Expertise on Quality & Regulatory

Are you looking to develop a safe medical device which is reliable and meets the requirements of regulations and customers within time and budget? 

Our integration of reliability, design for six sigma, regulatory and project management has made us a unique competence center for medical device development. 

We are experienced in, amongst others, setting up technical documentation conform MDR and IVDR, clinical studies, quality management, and risk management.

 

Talk to a specialist
Abstraction (Medical Records) Access Control Accreditation Acute Care Documentation Administrative Data Advance Directive Ambulatory Record Analytics (Healthcare) Annotation Application Service Provider (ASP) Audit Trail Authentication Authorization Automated Coding Backup Barcode Scanning Bedside Documentation Billing Documentation Biometric Authentication Blood Pressure Record Breach Notification Business Continuity Plan Benchmarking C Care Plan Case Management Documentation Case Report Form (CRF) Chart Review Clinical Documentation Clinical Documentation Improvement (CDI) Clinical Decision Support (CDS) Clinical Data Repository (CDR) Clinical Guidelines Clinical History Clinical Note Coding Compliance Coding System Confidentiality Consent Form Continuity of Care Document (CCD) Controlled Vocabulary Copy Forward Corrective Action Documentation Critical Incident Report Cross-Reference D–E Data Accuracy Data Analytics Data Entry Data Governance Data Integrity Data Management Plan Data Migration Data Security Data Standardization Data Validation Database Management Decision Support Documentation De-Identification Digital Signature Disclosure Authorization Document Control Document Imaging Document Lifecycle Document Management System (DMS) Documentation Audit Documentation Error Documentation Guidelines Documentation Policy Documentation Standard Documentation Template Double Documentation E-Consent EHR Access EHR Audit EHR Interoperability EHR Migration EHR Security Electronic Health Record (EHR) Electronic Medical Record (EMR) Electronic Signature Encounter Note Encryption Error Correction Evidence-Based Documentation Exemption Documentation F–H File Retention File Transfer Protocol (FTP) Financial Documentation Flowsheet Documentation Follow-Up Note Form Design Form Template Functional Status Documentation GDPR Compliance (EU) General Ledger Documentation Health Information Management (HIM) Health Level 7 (HL7) Health Record HIPAA Compliance (US) Historical Record Hospital Documentation Hyperlinking (Digital Records) I–L ICD-10 Coding ICD-11 Coding Identification Number Image Documentation Immunization Record Informed Consent Inspection Report Interdisciplinary Note Interoperability Inventory Documentation Issue Tracking Legal Hold Legal Record Liability Documentation Licensing Documentation Life Cycle Management Linkage Location Tagging Longitudinal Record Logging Loss Prevention M–N Maintenance Record Managed Care Documentation Manual Chart Master Patient Index (MPI) Metadata Metadata Tagging Microfilm Mobile Health Documentation Monitoring Report Narrative Note National Provider Identifier (NPI) Network Security Note Templates Notification Log Numbering System O–P Object Storage Observational Data OCR (Optical Character Recognition) Office Visit Note Offsite Storage Onboarding Documentation Open Notes Operational Documentation Order Entry Documentation Outpatient Record Overdue Documentation Alert Payer Documentation Paper Chart Paperless Record Patient Consent Patient Demographics Patient Education Documentation Patient Identification Patient Intake Form Patient Portal Patient Record Patient Safety Documentation Peer Review Documentation Performance Documentation Personal Health Record (PHR) Permission Access Policy Documentation Procedure Documentation Process Documentation Problem List Progress Note Proof of Care Documentation Protocol Documentation Protected Health Information (PHI) Provider Documentation Proxy Access Public Health Reporting Q–R Quality Assurance Documentation Quality Control Record Quality Improvement Documentation Questionnaire Form Radiology Report Record Accuracy Record Audit Record Classification Record Copy Record Retention Schedule Record Security Record Storage Record Transfer Recovery Documentation Referral Note Regulatory Compliance Release of Information (ROI) Remote Access Documentation Reportable Event Documentation Repository Request Form Risk Assessment Record Risk Management Documentation Role-Based Access Round Notes Routine Documentation S Scan Verification Scanned Document Security Protocol Security Token Service Documentation Signature Verification Snapshot Record Social History Documentation Software Audit Software Version Control Standard Operating Procedure (SOP) Standardized Form Standardized Template Storage Media Structured Data Subpoena Documentation Summary Record Surgical Note System Audit System Integration System Log System Security Synchronous Documentation Synthetic Record T–Z Telehealth Documentation Template Library Text Mining Time Stamp Transcription Transcribed Note Transfer Record Treatment Plan Triage Note Troubleshooting Documentation Unauthorized Access Prevention Uniform Record Unstructured Data Update Log Upload Verification User Authentication User Role Version Control Virtual Health Record Virtual Repository Vital Signs Documentation Voice Recognition Documentation Workflow Documentation Worklist Management XML Record Format X-Ray Report Yearly Audit Zero Deficiency Record Zoning (Access Control) Audit Trail Review Clinical Audit Report Coding Audit Data Backup Verification Data Encryption Data Masking Data Recovery Plan Data Retention Policy Digital Imaging Digital Record Access Disaster Recovery Document Approval Workflow Document Indexing Document Retrieval Document Versioning Electronic Signature Log E-Prescription Documentation File Compression File Encryption Healthcare Analytics Record Incident Documentation Information Lifecycle Management Interoperable Records Legal Documentation Audit Metadata Extraction Patient Data Anonymization Patient History Documentation Protected Document Access Quality Metrics Documentation Record Duplication Record Indexing Remote Record Access Retention Schedule Compliance Security Audit Structured Query Record Telemedicine Record Traceability Log Treatment Documentation Unstructured Record Extraction Usage Log User Access Audit Version Audit Workflow Optimization XDS (Cross-Enterprise Document Sharing) XML-Based Records Year-End Documentation Audit Zero Loss Policy

When to call us.

Holland Innovative (HI) can assist you in your medical device development journey. Our experts have many years of in-depth experience in regulations, medical device development, having worked at multinational medical companies, SME’s and MedTech start-ups. Each individual HI team member has a strong background in physics, electronics, software, mathematics, technical medicine and biomedical engineering. We know it takes the combination of technical knowledge, regulatory understanding, and soft skills to move forward together.

When you have questions about:

  • MDR 2017/745
  • IVDR 2017/746
  • Quality Management ISO 13485
  • Risk Management ISO 14971
  • Usability Engineering IEC 62366
  • Medical device software development IEC 62304
  • Combinational products 
  • Clinical evaluation
  • Performance evaluation
  • Product and Process Verification & Validation

HI-Basic QMS

Collaborating with the HI MedTech team, means benefitting of the HI-Basic Quality Management System, which includes procedures and templates for ISO 13485 related processes, including templates for Technical File documents. We can support in preparing these documents, given hands-on support in executing these studies and analyzing the results. 

What we can do.

Let's talk about the specifics.

Project management

Our experienced project managers will bring the right focus to your medical device development project, your QMS implementation, or regulatory compliance project.

More about our way of working
ABR (Auditory Brainstem Response) Accelerometer Sensor Accuracy Active Implantable Device Additive Manufacturing (3D Printing) Adhesive Sensor Adverse Event Alarm Systems Algorithm Validation Alignment Tools Ambient Sensors Anaesthesia Device Analytical Device Anesthesia Monitoring Antibiotic-Coated Device Application Programming Interface (API) Artificial Organ Assistive Device Autoclave Automated Dispensing Automated External Defibrillator (AED) Automated Monitoring Automated Testing Battery Management Biocompatibility Biodegradable Material Biofeedback Device Bioinstrumentation Biomechanical Sensor Biometrics Biomedical Device Biomedical Engineering Biomedical Imaging Biosensor Blood Glucose Monitor Blood Pressure Monitor Bluetooth Medical Device Body Area Network (BAN) Bone Fixation Device Brain-Machine Interface Breath Analyzer Buffered Drug Delivery Bug Tracking (Software) Button Sensor C Calibration Calibration Certificate Capnography Device Cardiac Device Cardiac Monitoring Cardiovascular Device Case Report Form (CRF) Catheter CE Marking Clinical Decision Support System (CDSS) Clinical Evaluation Clinical Validation Cloud Connectivity Closed-Loop Control Cochlear Implant Coding Compliance Component Testing Compliance Standards Computer-Assisted Surgery (CAS) Conformity Assessment Connectomics Device Contact Sensor Continuous Glucose Monitoring Control Algorithm Controller Area Network (CAN) Cryotherapy Device D–E Data Acquisition Data Logging Data Security Data Transmission Decision Support Defibrillator Delivery System Diagnostic Device Diagnostic Imaging Disposable Device Distributed System Dosimeter Drift Analysis Drug-Device Combination Durability Testing EHR Integration ECG Device EEG Device Electronic Health Record (EHR) Electronic Medical Record (EMR) Electromechanical Device Electrocardiograph Electroencephalograph Electromyography Electroporation Device Embedded System Emergency Device Endoscope Endovascular Device Environmental Testing F–H FDA Clearance FDA Approval Feedback Control Fiber Optic Sensor Filter Device Firmware Validation Flow Sensor Functional Testing Fusion Imaging Fuzzy Logic Control Gait Analysis Device Gas Sensor Gene Sequencer Gesture Control Device Glucose Sensor Gold Standard Validation GPS-Enabled Device Handheld Device Health Monitoring Device Heart Rate Monitor Hemodialysis Device Hemodynamic Monitoring High-Risk Device Holter Monitor Hospital Equipment I–L Identification Sensor Imaging Device Implantable Device Implantable Cardioverter Defibrillator (ICD) Infusion Pump Information Security Inhaler Device Instrument Calibration Instrument Sterilization Integrated Circuit Device Interface Design Interoperability IoMT (Internet of Medical Things) ISO 13485 ISO 14971 (Risk Management) ISO 10993 (Biocompatibility) Lab-on-a-Chip Laser Therapy Device Leadless Pacemaker Leak Testing Life-Support Device Linear Actuator Load Sensor Localization Device Low-Power Device M–N Maintenance Plan Magnetic Resonance Imaging (MRI) Malfunction Detection Material Testing Mechanical Device Medical Device Software Medical Imaging Medical Robotics Medical Sensor Medical Software Validation MedTech Regulatory Compliance Microfluidics Device Microcontroller Unit (MCU) Microelectromechanical System (MEMS) Minimally Invasive Device Monitoring Device Motion Capture Device Multi-Parameter Monitor Multi-Sensor Device Nanosensor Nanotechnology Device Networked Device Neural Interface Neurostimulation Device Non-Invasive Device Normative Data O–P Obstructive Device Observational Study Device Occupational Health Device Offline Testing Open-Loop System Optical Sensor Optical Imaging Oxygen Sensor Pacemaker Patient Monitoring Patient-Specific Device Pediatric Device Performance Qualification Peripheral Device Personal Medical Device Pharmaceutical Device Photoplethysmography Device PICC Line Pipeline Device Platform Technology Point-of-Care Device Portable Device Power Supply Validation Predictive Analytics Q–R Quality Assurance Quality Control Quality Management System (QMS) Radiation Therapy Device Radiation Sensor Radiography Device Real-Time Monitoring Record Keeping Reusable Device Regulatory Submission Regulatory Standards Remote Monitoring Reliability Testing Reprocessing Device Residual Risk Respiratory Device Robotic Surgery Risk Assessment Risk Classification Risk Management Plan Robotic Exoskeleton S Safety Assessment Safety Device Safety Standards Scalability Sensor Calibration Sensor Fusion Simulation Testing Signal Processing Single-Use Device Software as a Medical Device (SaMD) Software Validation Software Verification Software Update Sterilization Validation Stress Testing Structural Testing Subsystem Validation Surgical Device Surgical Navigation Sustainability System Integration System Testing System Verification System Validation Syringe Pump Synthetic Biology Device T–Z Telemedicine Device Telemonitoring Device Temperature Sensor Therapeutic Device Tissue Engineering Device Tool Validation Toxicology Testing Device Traceability Transducer Transmission Testing Treatment Planning Device Ultrasound Device Uninterrupted Power Supply (UPS) User Interface Design User Training Validation Protocol Verification Protocol Ventilator Video Laryngoscope Virtual Reality Medical Device Vital Signs Monitor Wearable Device Wireless Medical Device Workflow Integration X-Ray Device X-Ray Detector X-Ray Imaging X-Ray Tube X-Ray Validation XML Device Interface Yearly Maintenance Yield Testing Zero Defect Manufacturing Zero-Fault Testing Zigbee Medical Device Zone Monitoring Z-Score Validation Zonal Calibration Zoom Imaging Device Z-Plasty Tool Z-Axis Sensor Z-Axis Stage Z-Calibration Zero-G Device Zero-Error Tolerance Zigzag Scan Device Z-Positioning Z-Reference Z-Offset Calibration Z-Inspection Z-Protocol Z-Sensor Calibration Z-Threshold Test

Quality

Holland Innovative has an extensive track record in setting up quality management systems for medical device development. We offer support for setting up a complete ISO13485 compatible quality management system from scratch, extending a ISO9001 system or completing gap-analyses. 

Why we can take on your challenge
Acceptance Criteria Audit Trail Abbreviations List Abstract Document Access Control Adverse Event Report Approval Workflow Annex (Regulatory Document) Application Form Artifact As-Built Document Asset Inventory Audit Report Automated Document Control Authorized Signatory Backup Documentation Batch Record Bill of Materials (BOM) Biocompatibility Report Bibliography Binding Document Business Continuity Plan (BCP) Baseline Document C Calibration Record CAPA (Corrective and Preventive Action) Change Control Change Request Clinical Evaluation Report (CER) Clinical Investigation File Clinical Study Report (CSR) Closed Document Management Code of Federal Regulations (CFR) Commercial Documentation Compliance Document Component Specification Configuration Management Contract Documentation Control Log Controlled Copy Control of Documents Corrective Action Report Cross-Reference Table Customer Requirements D–E Data Sheet Data Integrity Data Management Plan Data Protection Data Sheet Revision Design History File (DHF) Design Input Design Output Design Review Design Verification Device Master Record (DMR) Deviations Log Document Approval Document Archive Document Classification Document Control Document Index Document Management System (DMS) Document Numbering Document Owner Document Retrieval Document Review Document Retention Document Revision Document Status Document Version Draft Document E-document E-signature Electronic Records Electronic Submission Electronic Workflow Emergency Change Documentation Engineering Change Notice (ECN) Engineering Change Order (ECO) Equipment Qualification Error Report Evidence File Exemption Request External Documentation Executive Summary F–H FDA Submission Field Service Report Filing System Final Report Form Template Functional Specification Functional Testing Documentation Gap Analysis Report Good Clinical Practice (GCP) Document Good Documentation Practice (GDP) Good Manufacturing Practice (GMP) Document Guidelines Hazard Analysis Health Authority Submission Historical Record Hyperlink in Document Handover Document Hardware Specification High-Level Design Document I–L Identification Number Impact Assessment Incident Report Indexing Inspection Report Installation Qualification (IQ) Instruction for Use (IFU) Integrated Documentation Internal Audit Report Internal Review ISO 13485 Documentation ISO 14971 Documentation Issue Log Job Instructions Key Document Knowledge Base Labeling Document Layout Drawing Legal Hold License Documentation Lifecycle Documentation List of Abbreviations Logbook M–N Maintenance Record Manufacturing Record Material Certificate Master Document Master File Meeting Minutes Metadata Method Validation Report Microfilm Monitoring Report Nonconformance Report (NCR) Nonconformity Log Note Sheet Notification Record Numbering System O–P Obsolete Document Off-Site Storage Online Documentation Operational Qualification (OQ) Operator Instructions Order Form Original Document Outbound Document Outdated Document Packaging Specification Paperless System Patient Information Leaflet Patent Document Performance Qualification (PQ) Policy Document Procedure Document Process Documentation Product Dossier Product Master Record Product Specification Project Documentation Protocol Document Publication Purchase Order Purpose Statement Q–R Quality Audit Report Quality Control Document Quality Manual Quality Metrics Quality Policy Quality Plan Quality Record Quality System Document Qualification Protocol Record Retention Schedule Record Review Records Management Regulatory Filing Regulatory Submission Release Note Report Template Research Documentation Review Log Revision History Risk Analysis Report Risk Management File Risk Mitigation Plan Root Cause Analysis (RCA) Report Router Document S Safety Report Sample Record Sanitation Documentation Scope Document Secure Document Storage Security Log Sensitivity Analysis Report Service Record SOP (Standard Operating Procedure) Source Document Specification Sheet Spreadsheet Stakeholder Review Standard Form Standard Template Status Report Storage Location Structured Document Submission File Supplier Document System Documentation System Log System Validation Record Software Documentation Software Requirement Specification (SRS) Software Testing Report Specification Change Notice Specification Revision Specification Verification Statistical Analysis Report T–Z Test Case Document Test Plan Test Protocol Test Report Technical Document Technical File Technical Note Technical Specification Template Library Traceability Matrix Training Document Training Record Trend Report Troubleshooting Document UDI Documentation (Unique Device Identification) Uncontrolled Copy Update Log Usage Log User Manual Validation Document Validation Report Verification Document Verification Report Version Control Version History Visual Documentation Workflow Document Workflow Log XML Document X-Ray Documentation Year-End Audit Report Yearly Review Zero Defect Documentation Zero Error Log Zonal Storage Z-Inspection Z-Protocol Z-Sensor Calibration Zigzag Review Log Zone Mapping Z-Axis Calibration Z-Threshold Record Z-Reference Document Z-Position Log Zoomed View Document Z-Coordinate Record Zero Hour Log Zero Fault Documentation Zero Loss Record Z-Validation Record Z-Sector Storage Z-Level Control Z-Check Report Zigzag Scan Report Zonal Audit Z-Indexing Z-Status Log Z-Approval Record Z-Compliance File Zero-Backlog Record Zero-Deficiency Audit Zero-Error Verification Zigzag Index Zone-Based Review Z-Tagging System Z-Workflow Tracking Z-Document Repository Z-Sector Verification Z-Level Audit Zero-Discrepancy Log Zero-Penalty Report Z-Threshold Audit Zigzag Documentation Control Zone Compliance Check Z-Sector Record Z-Audit Trail Z-Verification Record Z-Approval Workflow Z-Documentation Matrix Z-Reference Matrix

Regulatory

We offer support in setting up the complete technical documentation for your medical device, from drafting requirements to clinical evaluation.  

We are also experienced in complete business transitions from MDD to MDR and IVD to IVDR.

Acceptance Criteria Acceptance Sampling Accreditation Action Plan Activity-Based Costing (ABC) Audit Trail Auditing Authorized Representative Automation in Quality Baseline Benchmarking Best Practice Binding Standard Board Quality Committee Business Continuity Plan (BCP) Business Process Management (BPM) Batch Record Balanced Scorecard Big Data Analytics (Quality) Breakthrough Improvement C Calibration Capability Analysis Cause-and-Effect Diagram Change Control Change Management Check Sheet Certification Certified Auditor Checklist Client Requirements Closed-Loop Process Compliance Compliance Audit Component Quality Continuous Improvement Control Chart Control Plan Corrective Action Corrective and Preventive Action (CAPA) Cost of Quality (CoQ) Customer Complaint Customer Feedback Customer Satisfaction Customer Survey Cycle Time D–E Data Analysis Data Integrity Data Review Data Validation Decision Matrix Defect Defect Prevention Defect Tracking Deviation Documentation Document Control Documented Information Due Diligence Effectiveness Efficiency Electronic Records Employee Training Engineering Change Notice (ECN) Environmental Monitoring Error Proofing Escalation Procedure Evaluation Criteria Evidence Examination Report Exclusion Criteria F–H Failure Analysis Failure Mode and Effects Analysis (FMEA) Failure Rate Fault Tree Analysis (FTA) Feedback Loop File Retention First Article Inspection (FAI) Flowchart Focus Group Formal Verification Functional Testing Functional Specification Gap Analysis Governance Hazard Analysis Health, Safety & Environment (HSE) High-Level Process Historical Data Histogram Human Factors I–L Identification of Requirements Impact Analysis Implementation Plan Improvement Plan Incident Report Inspection Inspection Report Internal Audit Internal Control Internal Quality Review ISO 9001 ISO 13485 ISO 14001 Issue Log Key Performance Indicator (KPI) Knowledge Management Labeling Control Lapse Analysis Lean Management Lessons Learned Lifecycle Management Licensing Requirements Line Clearance M–N Maintenance Record Management Review Management System Manufacturing Process Control Measurement System Analysis (MSA) Measurement Traceability Metrics Monitoring Monitoring Plan Nonconformance (NC) Nonconformity Report Nonconforming Material Notification Process Null Defect Policy Nuclear Quality Standards Number of Defects Number of Observations NPI (New Product Introduction) Normalization Note Sheet Nondestructive Testing (NDT) O–P Objective Observation Observation Report Occupational Health Off-Specification (OOS) On-Specification (OS) Open Nonconformance Operational Audit Operational Definition Operational Excellence Operational Process Operational Risk Order Review Output Specification Outsourcing Control Oversight P-F Curve Pareto Analysis Pareto Chart Patient Safety (Healthcare QMS) Performance Assessment Performance Indicator Performance Measurement Performance Review Periodic Review Personnel Competency Policy Policy Document Portfolio Management Post-Market Surveillance Pre-Approval Inspection Preventive Action Process Audit Process Control Process Flow Process Improvement Process Mapping Process Measurement Process Optimization Process Owner Process Standardization Procedure Procedure Manual Product Audit Product Inspection Product Lifecycle Product Specification Product Verification Q–R Quality Quality Assurance Quality Audit Quality Control Quality Manual Quality Metrics Quality Objective Quality Policy Quality Plan Quality Record Quality Review Quality System Quantitative Analysis Qualification Quality Improvement Plan (QIP) Quarantine Material Regulatory Compliance Regulatory Filing Regulatory Review Reliability Testing Reporting Procedure Requirement Traceability Residual Risk Resource Planning Risk Assessment Risk Analysis Risk Management Root Cause Analysis S Safety Audit Safety Report Sample Inspection Sampling Plan Scorecard Scrap Rate Service Level Agreement (SLA) Shift Review Simulation Testing Six Sigma Six Sigma Tools Software Validation SOP (Standard Operating Procedure) Specification Specification Compliance Statistical Analysis Statistical Process Control (SPC) Stakeholder Review Standard Standardization Standard Operating Procedure Standard Work Instructions Status Report Supplier Audit Supplier Evaluation Supplier Qualification Supplier Scorecard Supplier Verification Sustainability System Audit System Control System Documentation System Integration System Review System Validation T–Z Team Competency Technical Document Technical File Technical Report Test Case Test Plan Test Report Traceability Training Record Training Plan Trend Analysis Trend Report Troubleshooting Document Turnaround Time (TAT) UDI (Unique Device Identification) User Requirement Specification (URS) Validation Validation Plan Validation Report Verification Verification Plan Verification Report Workflow Workflow Mapping Workflow Optimization Work Instruction Work Standard Year-End Review Yield Analysis Zero Defects Zero Failure Zero Nonconformance Zone Audit Zoning (Control) Z-Score Analysis Zigzag Audit Zigzag Control Zigzag Review Z-Indexing Z-Level Verification Z-Axis Compliance Z-Sector Review Z-Threshold Audit Z-Protocol Review Z-Documentation Check Z-Approval Record Z-Verification Matrix Zero Backlog Zero Discrepancy Zero Deficiency Zero Tolerance Zero Error Policy Zero Fault Zero Variance Z-Reference Control

Medical design for Six Sigma and data analytics

We use the methodology of Design for Six Sigma to collect the voice of the customer and translate these into measurable parameters — in other words, the Critical to Quality Characteristics (CTQ) for you to focus on during the medical device development. 

This results in a device which meets the requirements of both regulations and your users. By applying appropriate statistical analyses we ensure that your verification and validation results are reliable and useful. By using data science and data analytics we can support you in developing new value, service and business models when introducing your product. 

project_management_masterclass-1

Clinical Evaluation

With the knowledge of the requirements for
Clinical Evaluation and Post-Market Surveillance (PMS) (ISO/TR 20416:2020) as set out in the
Medical Device Regulation (MDR), including Clinical Investigation (ISO 14155), we can provide practical guidance on how to conduct clinical evaluations.

Our unique approach combines regulations with Six Sigma methods (e.g. to calculate sample sizes), Reliability (e.g. to determine the product lifetime), and Data Science (e.g. to analyse PMS data).

Acceptance Criteria Acceptance Sampling Accreditation Action Plan Activity-Based Costing (ABC) Audit Trail Auditing Authorized Representative Automation in Quality Baseline Benchmarking Best Practice Binding Standard Board Quality Committee Business Continuity Plan (BCP) Business Process Management (BPM) Batch Record Balanced Scorecard Breakthrough Improvement Budget Control C Calibration Capability Analysis Cause-and-Effect Diagram Change Control Change Management Check Sheet Certification Certified Auditor Checklist Client Requirements Closed-Loop Process Compliance Compliance Audit Component Quality Continuous Improvement Control Chart Control Plan Corrective Action Corrective and Preventive Action (CAPA) Cost of Quality (CoQ) Customer Complaint Customer Feedback Customer Satisfaction Customer Survey Cycle Time Critical Control Point (CCP) Cross-Functional Team Culture of Quality Current Process Analysis Capability Maturity Model (CMM) D–E Data Analysis Data Integrity Data Review Data Validation Decision Matrix Defect Defect Prevention Defect Tracking Deviation Documentation Document Control Documented Information Due Diligence Effectiveness Efficiency Electronic Records Employee Training Environmental Monitoring Escalation Procedure Evaluation Criteria Evidence Examination Report Exclusion Criteria External Audit External Supplier Evaluation F–H Failure Analysis Failure Mode and Effects Analysis (FMEA) Failure Rate Fault Tree Analysis (FTA) Feedback Loop File Retention First Article Inspection (FAI) Flowchart Focus Group Formal Verification Functional Testing Functional Specification Gap Analysis Governance Hazard Analysis High-Level Process Histogram Human Factors Historical Data Handling Instructions I–L Identification of Requirements Impact Analysis Implementation Plan Improvement Plan Incident Report Inspection Inspection Report Internal Audit Internal Control Internal Quality Review ISO 9001 ISO 13485 ISO 14001 Issue Log Key Performance Indicator (KPI) Knowledge Management Labeling Control Lapse Analysis Lean Management Lessons Learned Lifecycle Management Licensing Requirements Line Clearance List of Abbreviations Legal Compliance M–N Maintenance Record Management Review Management System Manufacturing Process Control Measurement System Analysis (MSA) Measurement Traceability Metrics Monitoring Monitoring Plan Nonconformance (NC) Nonconformity Report Nonconforming Material Notification Process Null Defect Policy Number of Defects Normalization Note Sheet Nondestructive Testing (NDT) Needs Assessment Network Audit O–P Objective Observation Observation Report Occupational Health Off-Specification (OOS) On-Specification (OS) Open Nonconformance Operational Audit Operational Definition Operational Excellence Operational Process Operational Risk Output Specification Outsourcing Control Oversight P-F Curve Pareto Analysis Pareto Chart Performance Assessment Performance Indicator Performance Measurement Performance Review Periodic Review Personnel Competency Policy Policy Document Portfolio Management Post-Market Surveillance Preventive Action Process Audit Process Control Process Flow Process Improvement Process Mapping Process Measurement Process Optimization Process Owner Process Standardization Procedure Procedure Manual Product Audit Product Inspection Product Lifecycle Product Specification Project Documentation Protocol Q–R Quality Quality Assurance Quality Audit Quality Control Quality Manual Quality Metrics Quality Objective Quality Policy Quality Plan Quality Record Quality Review Quality System Quantitative Analysis Qualification Quality Improvement Plan (QIP) Quarantine Material Regulatory Compliance Regulatory Review Reliability Testing Reporting Procedure Requirement Traceability Residual Risk Resource Planning Risk Assessment Risk Analysis Risk Management Root Cause Analysis Review Log Review Meeting Record Retention S Safety Audit Safety Report Sample Inspection Sampling Plan Scorecard Scrap Rate Service Level Agreement (SLA) Shift Review Simulation Testing Six Sigma Software Validation SOP (Standard Operating Procedure) Specification Specification Compliance Statistical Analysis Statistical Process Control (SPC) Stakeholder Review Standard Standardization Standard Operating Procedure Standard Work Instructions Status Report Supplier Audit Supplier Evaluation Supplier Qualification Supplier Scorecard Supplier Verification Sustainability System Audit System Control System Documentation System Integration System Review System Validation T–Z Team Competency Technical Document Technical File Technical Report Test Case Test Plan Test Report Traceability Training Record Training Plan Trend Analysis Trend Report Troubleshooting Document Turnaround Time (TAT) User Requirement Specification (URS) Validation Validation Plan Validation Report Verification Verification Plan Verification Report Workflow Workflow Mapping Workflow Optimization Work Instruction Work Standard Year-End Review Yield Analysis Zero Defects Zero Failure Zero Nonconformance Zero Tolerance Zero Error Policy Zero Fault Zero Variance Zoning (Control) Z-Axis Verification Z-Sector Review Z-Threshold Audit Z-Documentation Check Z-Approval Record Z-Verification Matrix Zero Backlog Zero Discrepancy Zero Deficiency Zigzag Audit Zigzag Control Zigzag Review Z-Indexing Z-Level Verification
https://www.holland-innovative.nl/hubfs/lisette.jpg
In order to put good and safe products on the market, it is necessary to plan certain activities in time during the design and production process.

Lisette van Steinvoren - Stamsnijder

Competence Lead MedTech & Sr Project Manager Medical

Let's talk about your challenge.

Our experience and excellence in the execution of our projects can be valuable tools to help you further in your personal development and in the growth of your company.

People talking-1

Ready to take on the next challenge.

Together with you, we face the challenge to share the future and take further steps towards value creation and social impact. 

Talk to a specialist
Get to know us