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, 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).

Confirmed program (Updated June 21, 2021)

Download the full program, speaker information and conference facts (PDF) →

Day 1 – Biological Evaluations

Session 1: News and updates to ISO 10993

  • 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
  • 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
  • After chemical characterization, do I still need genotoxicity studies?
    Dr. Hana Hofman-Huether, Founder of H3 Consulting Services, Convener of WG 6, ISO/TC 194 (ISO 10993-3)

Session 2: Experience from industry, Notified Bodies and CROs

  • Biological Evaluation Submission’s Common Mistakes – Notified Body Experience
  • Chances and challenges of Chemical characterization – a case study
    Dr. Elisabeth Mertl, OFI, Österreichisches Forschungsinstitut für Chemie und Technik
  • 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
  • Challenges to evaluate the biological safety of reusable medical devices over their whole life-cycle
    Dr. Lise Vanderkelen, Nelson Labs

Session 3: 3R -Biocompatibility testing in vitro

  • In vitro skin irritation testing of medical devices
    Dr. Kristina Fant, RISE Research Institutes of Sweden
  • 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

Session 4: More aspects on biological safety

  • Biocompatibility evaluation of breathing gas pathways in health care applications, proposed changes to the ISO 18562 series
    Prof. Lars-Magnus Bjursten at Lunds University
  • Hemocompatibility assessment of devices with circulating blood contact: Practical considerations for experimental design and data interpretation
    Dr. 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
  • Methods for biological evaluation of drug-device combination products.
    Dr. Gaëlle Clermont,  Senior Product Development Strategist, NAMSA
  • Panel/interactive discussion:
    Making complex things easier – how can we optimize the synergies between the biological and clinical evaluation?

Day 2 – Clinical evaluations

Session 5: Clinical evaluations, requirements & sufficient data

  • Clinical Data Requirements with the EU MDR – What is sufficient?
    Dr. Bassil Akra, CEO and Owner of AKRA TEAM GmbH
  • Clinical evaluations- how to handle gaps in clinical data
    Gianluca Colucci, Intertek
  • Medical Devices outside EU

Session 6: Clinical investigations, news & updates

  • Updates ISO 14155 including approvals for clinical investigations
    MD101 Consulting
  • Clinical trials/Investigator lead
  • PMCF- experience from collecting real life data
    Christina Östberg Lloyd, CEO, Pharmiva AB

Session 7: Experiences from manufacturers, lessons learned

  • Case study – Class I
    Anna Sahlholm, Medical Science Liaison & Product Owner at Abilia
  • Case study – Software
    David Hedfors, RaySearch
  • Case study- Emergency medicine
    Fredrik Arnwald, Director of Clinical Affairs at Stryker

Session 8: Panel discussion and conclusion

  • Healthcare perspective/ Importance of patient safety
  • Panel discussion
    Speakers from conference

Stay tuned with the program – 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: Due to EU Directive 2006/112/EC  local VAT (25%) is added. (See also: Council Implementing Regulation (EU) No 282/2011).
This VAT is refundable for tax registered companies. More information (PDF) →


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


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

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



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