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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Team Enschede Medical

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
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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
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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.

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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. 

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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).

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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.

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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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