Nyt kursus: Biological Equivalence and Global Compliance - Implementation of ISO 10993

Medicoindustrien udbyder et nyt kursus i samarbejde med NAMSA. Kurset Biological Equivalence and Global Compliance - Implementation of ISO 10993 afholdes den 29. oktober 2021, og tilmelding er nu åben.

Course objective and outcome
The course takes a deeper dive into two key areas; understanding and applying MDR requirements for demonstrating biological equivalence, and, global biological safety requirements – demonstrating compliance and developing a successful biocompatibility strategy for markets around the world.
Now that MDR is a reality, we will take the opportunity to look more closely at the impact and requirements of the regulation, including a Q&A with a former Notified Body auditor.
Retaining the successful format of training presentations followed by Q&A, workshops and manufacturer case studies, this experiential, hands-on course will benefit anyone who is responsible for, or concerned with, biological safety in their organization. 
Biological Equivalence and MDR:

  • Learn how to demonstrate biological equivalence to comply with MDR requirements for biological equivalence in the MDCG-5 guideline
  • Overview of requirements in MDCG-5 guideline
  • Overview of the requirements of ISO 10993-18:2020 Annex c
  • Practical examples on how to document biological equivalence
  • Potential pitfalls and how to avoid them

Global Compliance - Implementation of ISO 10993:

  • Biocompatibility documentation according to different countries:
    • EU
    • US FDA
    • Asia: Japan, China, South Korea etc
    • Rest of World: Russia, Brazil etc
  • With focus on similarities and differences – and best practice for global biosafety compliance strategy

The course format is a combination of online and onsite training meaning the participants will meet physically at Medicoindustrien in Hørsholm and receive the training online on a big screen transmitting the trainer directly from Namsa, USA. The case studies will be onsite training.

Who should attend
This course is targeted towards those who have a working knowledge of biocompatibility and are looking to update and sharpen their skills, in the light of new updates and developments.

  • Biosafety specialists
  • Biocompatibility specialists
  • Material specialists
  • Risk managers
  • Regulatory specialists and managers
  • Product design engineers
  • Clinical affair specialists and managers
  • Quality assurance specialists and managers

Don Pohl, Principal Product Development Strategist, Namsa
MDR Expert, Namsa
Annette Bitz, Head of Biosafety, Ambu

Læs mere og tilgå tilmelding her


bm@medicoindustrien.dks billede
Berit Munkebo