February 19, 2020 Posted by Efclin

EUROMCONTACT in collaboration with EFCLIN invites you to a workshop on risk assessment on 6th March 2020, in Brussels.
Objective of the workshop
The workshop aims at supporting members of EUROMCONTACT to prepare their risk assessment files under the new requirements of the Medical Devices Regulation (MDR).
The MDR puts a lot emphasis on the risk-based approach. In that context the workshop would address methodology to best perform the risk assessment for several subjects, including:
- Manufacturing process
- Operational procedures
- Products risk assessment
- Inclusion of new standard on risk assessment.
The workshop will be combination of guidance/ check list and explanation what is expected from Notified Bodies and Competent Authorities, and practical implementation.
Consultant- Trainer
Stefan Menzl is a consultant at QSERVE Consultancy. Before joining QSERVE, Stefan was Gloval VP Quality and Regulatory Affairs at Paul Hartmann AG. In course of his career, Stefan worked as Director Regulatory Affairs, Compliance and Clinical Research for EMEA region for AMO and then as Director International Regulatory Affairs. Stefan holds a Master degree in Biology and a PhD in Biotechnology.
Sonja is a consultant at Qserve Consultancy. Sonja started her carrier as a Researcher at University of Leiden, department of Biomaterials and worked on the development of biodegradable polymers and ceramic filler materials. She was involved in setting up a spin-off company in biological safety testing, performing both routine tests and developing mechanical and chemical characterisation tests based on ASTM standards. She has been a member of the Dutch Standardization committee for the development of biological safety evaluation tests and worked for a Notified Body as Lead Auditor and technical file reviewer. Sonja has a bachelor’s degree in Life Sciences (histology, cytology and pathology).
Workshop is open to all members of EUROMCONTACT and EFCLIN. Registration fees is 200€.
Application can be send to

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