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