Biological Equivalence and Global Compliance - Implementation of ISO 10993

This new 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.

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. 
 
Content
 
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 (MDR, including 10.4)
    • US (FDA)
    • Asia i.e. Japan, China, South Korea 
  • 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

Trainers
Don Pohl, Principal Product Development Strategist, Namsa
Michelle Kelly, Toxicologist, Namsa
Annette Bitz, Head of Biosafety, Ambu
Daniel Vest Christoffersen, Ambu

Indtast et "Purchase order number" hvis din virksomhed forlanger det på fakturaen.

Kontakt

mp@medicoindustrien.dks billede
Morten Petersen
Uddannelseskonsulent
49184703