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.

 

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setting up technical documentation conform MDR and IVDR, clinical studies, quality management, and risk management

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
Medical project manager

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
Medical quality assurance iso13485

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.

Medical regulatory MDD to MDR

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. 

Medical design for six sigma, 6 sigma

Medtech 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.

Medtech quality assurance QA

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. 

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