Biological and Clinical Evaluations Conference for Medical Devices

a Key2Compliance® Continued Development Conference - October 5-6, Malmö, Sweden

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
  • 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?

Confirmed speakers
Click here for full program presentation (PDF updated May 12th) →

  • Clinical Data Requirements with the EU MDR – What is sufficient?
    Dr. Bassil Akra, CEO QUNIQUE GmbH
  • Updates on ISO 10993 and ISO 18562
    Prof. Lars-Magnus Bjursten at Lunds University, Convener ISO TC121/SC3/WG13 (ISO 18562 series), Chairman for the Swedish mirror committees for ISO TC 150 (surgical implants) and ISO TC 194 (ISO 10993 series)
  • Safety is more than biocompatibility:
    MDR generals requirements and ISO 10993 series

    Paolo Pescio, ERT, Senior Scientific Director Medical Devices, Eurofins Biolab
  • Chances and challenges of Chemical characterization – a case study
    Elisabeth Mertl, OFI, Österreichisches Forschungsinstitut für Chemie und Technik
  • Hemocompatibility assessment of devices with circulating blood contact: Practical considerations for experimental design and data interpretation
    Crystal D’Silva, Research Scientist, Biocompatibility lead for Baxter’s Acute Renal and Nutrition product portfolio, Life Sciences & Operations, Baxter, Member of the ISO/TC 194 WG 5, 9, 12, & 15
  • Setting up a process for clinical data generation according to MDR – building on existing knowledge and relations
    Anna Sahlholm, Medical Science Liaison & Product Owner at Abilia
  • Experiences from clinical trials in emergency medicine
    Fredrik Arnwald, Director of Clinical Affairs at Stryker
  • Managing uncertainty in the toxicological risk assessment
    Dr. Ryan Paul Wheeldon, Manager, Research and Development at Baxter International Inc. member of the ISO/TC 194 WG 6 and WG 11
  • ISO 10993-18: Which extraction strategy might be adequate for my medical device?
    Jan Peeters, Senior Consulting Specialist, Eurofins BioPharma Services Consulting Munich, Germany, member of the ISO/TC 194 WG 1, 2, 11, 14, 15, ISO TC 172 SC07 WG 7, ISO/TC 198/WG 7
  • In vitro skin irritation testing of medical devices
    Kristina Fant, RISE Research Institutes of Sweden
  • After chemical characterization, do I still need genotoxicity studies?
    Hana Hofman-Huether, Founder of H3 Consulting Services, Convener of WG 6, ISO/TC 194 (ISO 10993-3)
  • In-vitro skin sensitization tests in the biological evaluation
    David Waeckerlin, Sonova
  • In-vitro testing for endocrine disruptive properties of medical devices
    Dr. Peter Behnisch, BioDetection Systems
  • Challenges to evaluate the biological safety of reusable medical devices over their whole life-cycle
    Dr. Lise Vanderkelen, Nelson Labs
  • The clinical development journey for Pharmivas products
    Christina Östberg Lloyd, CEO, Pharmiva AB

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

990,00 850,00

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

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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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