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).
Confirmed program (Updated Oct 1st, 2021)
Day 1 – Biological Evaluations
Session 1: News and updates to ISO 10993
- Updates of the ISO 10993 series (Biological evaluation of medical devices
— Evaluation and testing within a risk management process) and what to expect for the future
Prof. Lars-Magnus Bjursten at Lund 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
- 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
- Chances and challenges of Chemical characterization
Dr. Elisabeth Mertl, OFI, Österreichisches Forschungsinstitut für Chemie und Technik
- Biological Evaluation Submission’s Common Mistakes – Notified Body Experience
Jocelyn Åkerberg, Key2Compliance AB
- 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
- Experience of using in vitro sensitization methods for medical devices
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?
Workshops: Clinical Evaluation and Investigation (Parallel with session 3 & 4):
- Software as medical device
Johanna Fugelstad, Key2Compliance AB
- Practicalities in a medical device clinical investigation
Paméla Stenström, Key2Compliance AB
Clinical Evaluation: how does it tie together with the technical file
Maria Lindgren, Key2Compliance AB
- Software as medical device
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
- Mind the gap. How to bring clinical practice and clinical evidence closer
(without forgetting the Manufacturers)
Gianluca Colucci, Intertek
- GCP according to ISO 14155 a global perspective
Danielle Giroud, MD-CLINICALS
Session 6: Clinical investigations, news & updates
- Medical device clinical investigations
Myriam Desmet, Health Care & Medical Devices Consulting
- Clinical Evaluation under MDR: Experience from a Notified Body Clinical Review of a class-III combination device
Kristina Ingvar, EVP Quality Management & Regulatory Affairs, BONESUPPORT
- Experience from collecting Real Life data and how PMCF requirements leverage long term value or How to Turn Challenges into Opportunities
Christina Östberg Lloyd, CEO, Pharmiva AB
- Putting clinical evidence in perspective and tying it all together
Maria Lindgren, Key2Compliance AB
Session 7: Experiences from manufacturers, lessons learned
- 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
- Machine Learning, Clinical Data and the Market Clearance Process
David Hedfors, RaySearch
- Experiences from clinical trials in emergency medicine
Fredrik Arnwald, Director of Clinical Affairs at Stryker
- On topic: Healthcare collaboration/ Importance of patient safety
Åse Ek, Key2Compliance AB
Session 8: Panel discussion and conclusion
- Panel discussion – Future challenges for Medtech
Speakers from conference and Martin Dræbye Gantzhorn, Bech-Bruun
Stay tuned with the program – It will be constantly/continually updated!
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
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
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) →
Information on Covid-19 related precautions and related terms (conditions).
Keeping distance: The venue itself as well as the seating in the conference room is spacious, to allow the attendees to maintain distance, as required by local recommendations and policies.
Additional safety measures: hand-disinfectants will be available, and all meeting areas are frequently cleaned.
Attend on-line: If you experience symptoms or suspect you might be infected and need to refrain from attending on site we can arrange for you to attend on the conference online. E-mail us if you want to receive information about this option.
Cancellation policy: In case neither on site or online attendance is an option you may cancel your registration with full reimbursement of the conference fee until September 20th (14 days before the conference start). If the cancellation is done 7 days, or later, before the conference start you will be charged 150 Euros. For cancellations done October 4th or later the full conference cost is charged.
Information on applicable national Swedish restrictions can be found here: