Medical Device Development in the EU: Be prepared for the Queue!

An introduction in Medical Device Development in Europe, starting with the explanation of roles & regulations and do’s and dont’s in order to get your device on the market.
Followed by an overview of the current situation in the field regarding certification of medical devices and the queues at Notified Bodies.
Closing with some tips to be prepared!

A presentation by Lisette van Steinvoren, Competence Lead MedTech at Holland Innovative.

View from the Speaker

Question 1: What drives you?
To get medical device innovations to the patient; so that they can benefit from it. I want to support during the development of these innovations to get through the ‘jungle’ of regulations & management challenges.

Question 2: Why should the delegate attend your session?
People involved in medical device development, especially when you’re not fully familiar with abbreviations like MDR, IVDR, NoBo, CE, QMS.

Question 3: What emerging technologies / trends do you see as having the greatest potential in the short and long run?
For the long run I see Regenerative Medicine and Artificial intelligence as high potential trends. On the short term personalized medicine, by using microfluidics are promising in my opinion.

Question 4: What kind of impact do you expect them to have?
Personalized approach, instead of ‘one size fits all’ will create a more effective treatment.
Using Artificial intelligence and the power of big data will improve cure and care in multiple ways; for example by better diagnosis and by optimal treatment planning.
Regenerative medicine will open up a whole new world of treatments to heal tissues and organs and to restore functions lost due to aging, disease, damage or defects. Regenerative Medicine employs various combinations of specially grown cells, tissues, and laboratory-made compounds to replace or amplify the body’s natural healing process.

Question 5: What are the barriers that might stand in the way?
The medical device regulation are on side an accelerator to develop these new innovations in a safe and controlled manner, on the other hand the form a barrier due to the amount of detail required in all standard and in some cases, like with AI it is unknown how to comply. Regulations & innovations evolve hand in hand, and that introduces ‘chicken & egg’ challenges.

About Lisette van Steinvoren
Lisette has a proven track record in project management, CE certification of Medical devices and setting-up & implementation of QMS systems according to ISO 13485. She has background in Applied Physics and Innovation Management. Lisette has extensive experience as a trainer and facilitating hands-on workshops regarding medical device development.

About Holland Innovative
We inspire people and organizations with leadership in product and process development, project management, reliability engineering, medical device development and data science.

Lisette van Steinvoren is speaker at the 2022 edition of the Health Tech Event.

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