Event info
Date:05 Oct - 06 Oct
Venue:Malmö
Contact person
Sofia Norås

Sofia Norås

Project Manager

sn@mva.org

+45 2337 0040

Biological and Clinical Evaluations Conference for Medical Devices

You are hereby invited to participate in a medical device regulatory conference: An international conference on medical device pre- and post-market strategies for biological evaluation, material characterisation and clinical evaluation and investigations. It is an opportunity to broaden your understanding and expand your professional network!

The conference supersedes the previous conferences – Symbioteq Biocompatibility of Medical Devices – now organised by Key2Compliance®, a Symbioteq company. The conference has a new format which we hope will suit your medical device needs and is designed to be valuable for both specialists and beginners. You will get the opportunity to hear the latest news from professionals within the fields of biocompatibility, clinical evaluations and investigations.

The conference is intended for professionals working with product safety, as material specialist, within material characterization, biological evaluation, or clinical investigations, post-market-clinical follow-up activities or clinical and performance evaluations, design and development, process development or Quality Assurance/Regulatory Affairs.

Date: 5 – 6th of October, 2021
Venue: Sankt Gertrud Conference, Malmö, Sweden

 

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Conference Outline: 

  • News and (coming) updates to the ISO 10993 and ISO 18532 series
  • MDR requirements related to biocompatibility
  • The role of chemical characterization in biological evaluation
  • How to perform clinical evaluation of legacy devices
  • How to develop a plan for clinical evaluation of new/innovative devices; strategy and elements to cover
  • Biological evaluation of drug-device combination products
  • In vitro testing of medical devices
  • The correlation and interaction between risk management, clinical development and biological evaluation and the role of post-market clinical follow-up (PMCF)
  • Clinical data requirements under MDR
  • How to collect clinical data with MDD/legacy device on market
  • Notified body perspective on typical errors in biological and clinical evaluations
  • Consideration when doing a medical device clinical investigation
  • What is new in the updated ISO 14155 standard?
  • Workshops (see below)

 

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