Expertise on QA&RA

Are you looking to develop a safe medical device which is reliable and meets the requirements of both regulations and customers? And do you need to accomplish this within time and budget deadlines?  

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

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Team Enschede Medical

How our MedTech experts can contribute to your organization:

Holland Innovative (HI) can assist you in your medical product development journey. Our experts have many years of in-depth experience in medical product 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. Our integration of Reliability, Design for Six Sigma, Regulatory and Project Management in medical device development has made HI a uniquely qualified competence center for medical device development. We know it takes the combination of technical knowledge, business understanding and soft skills to move forward together.

We’re more than ready to help identify your project and/or personal needs. By mapping out the development process we show how the competence areas of Regulatory, Reliability, Design for Six Sigma and Project Management are working together to successfully complete the design of your medical device.

The following questions are crucial in the success of the development process of your medical product:


  • Are you aware of all applicable regulations and standards?
  • Is your team well trained in these aspects? Do you need to bring your medical engineering team to a higher competence level?
  • Do you have a clear project timeline showing the correlation of all project competences, activities and deliverables?
  • Are Safety Risk Management, Usability Engineering and Clinical Evaluation in place?
  • Is your product developed in a structured and well documented way? According to the requirements of Quality Management Systems?
  • Is your team experienced in medical product development using the unique combination of Regulatory, Reliability, Design for Six Sigma, Data Analytics and Project Management?

Example projects in medical device development

By combining our knowledge of reliability engineering with our experience in project management our client was able to successfully develop a novel product on the mammography market.

We assisted the development of an MRI coil by focusing on critical customer need, resulting in an optimal design flexible enough to use in all applications.

What we can do.

Let's talk about the specifics.

Medical project management

Our experienced project managers will bring the right focus to your project team. Being trained in observing and identifying your challenges from a fresh perspective, finding the best solution for your specific situation.

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 work in complete agreement with all applicable regulatory requirements, such as Safety Risk Management based on ISO14971, Usability Engineering according to IEC and Software engineering according to IEC 62304. 

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Medical design for six sigma and data analytics

We use the methodology of design for six sigma to translate critical requirements for your medical device 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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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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