Biological and Clinical Evaluations Conference for Medical Devices

a Key2Compliance® Continued Development Conference

Biological and Clinical Evaluations 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.

Who is it for

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.

By attending this conference you will understand the intent of the regulators better and get a clear view of the path towards compliant technical documentation. Our speakers will represent both regulatory advisors, Notified Bodies, and the industry as well as other stakeholders (test labs, CROs and more).

Conference outline

  • News and (coming) updates to the ISO 10993 series
  • MDR requirements related to biocompatibility
  • How to perform biological evaluation of legacy devices
  • The role of chemical characterization in biological evaluation
  • How to perform clinical evaluation of legacy devices
  • Performance evaluations and investigations – what do they entail
  • How to develop a plan for clinical evaluation of new/innovative devices; strategy and elements to cover
  • 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 clinical evaluations
  • Consideration when doing a medical device clinical investigation
  • What is new in the updated ISO 14155 standard?

Stay tuned with this page – it will be constantly/continually updated!

Conference facts


October 5-6th, 2021


St Gertrud Conference in Malmö, Sweden.
Directions to hotels and conference will be provided after registration and posted on the web site


Not included in the fee and suggested nearby hotels with special fee for conference guest will be provided after registration and posted on the web site

Conference mingle

Evening the 5th after last session all guests are invited to a networking get-together      where refreshments and drinks (alcoholic/non-alcoholic) will be served

Conference fee

Early-bird until August 4th: 890 Euro (appr equal to 8 945 SEK or 6 650 DKK )
Full price from August 5th:  990 EUR (appr equal to 9 950 SEK or 7 400 DKK )
Discount: 3 persons or more 10% if registered and invoiced together.
The fee includes full participation at conference, get-together mingle and electronic copies of conference notes.
Note: 25 % local VAT will be added


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Date & Time
October 5, 2021
- October 6, 2021
See program.
IndustryMedical Device
LevelIntermediate, Specialist
VenueSankt Gertrud Conference

990,00 890,00

No. persons
Early bird price above to Aug 4th / 3 persons or more 10% if registered and invoiced together for the same course.

make an inquiry

In-House Training

This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.

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Your Instructor(s)

Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.



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