Other sectors

Introduction to biocompatibility for medical devices

Medical_Device_Regulation

This training will provide participants with an insight into biocompatibility, risk-based approach ISO 14971:2019, on the ISO 10993-1 and ISO 10993-18 standards. It will be helpful for Quality and Regulatory people who are involved in preparing Technical files and Design Dossiers and gives a hands-on knowledge of biocompatibility assessment, testing strategy and risk assessment approach.

About Introduction to biocompatibility for medical devices

Why this course:

The focus on biocompatibility has become stronger as the ISO standards are updated and the MDR is now in place. This course will give you an introduction and also give a route, the Biological Evaluation Plan, as to how to work with this task both from an ISO 10993-1 level and the MDR 2017/745 level. Chemical characterization is mandatory and we will go through this in more detail. 

Who should attend:

QA/RA, D&D, Clinical as well as suppliers of raw material.

What will you learn:

In this one day’ training you will get an overview of the requirements and the guidance documents in order for you to be able to establish a well-prepared Biological Evaluation Plan.

Content:

Module 1 (1 day) – Introduction to biocompatibility for medical devices with a risk-based approach:

  • ISO 10993-1 and ISO 14971
  • Biological Evaluation plan and MDR GSPR §10
  • US/FDA status
  • Raw materials, suppliers and manufacturers with respect to process aids and change control
  • ISO 10993-18 – what testing scenario to choose and why
  • Requirements on the test houses

Trainers:

The course is tutored by the below experienced trainers:

  • Anette Sjögren, MSc Biomedicine, Regulatory expert, 35 years in industry medical devices and pharmaceuticals, member of the international standardization work within medical devices.
  • Charlotte Trotzig, PhD polymer chemistry, Biocompatibility expert, 25 years in industry and member of the ISO 10993 working group.

Are you looking for a customised course?:

Content of the course can be changed and modified depending on the need of the customer for private/inhouse courses.

Please contact us for more information.

Kontakt os for yderligere information

Do you have any questions?

Contact us

Register for the training class here

REGISTER

Hvornår:

5. oktober 2023

Add to calendar 2023/10/05 09:00 2023/10/05 18:00 Introduction to biocompatibility for medical devices This training will provide participants with an insight into biocompatibility, risk-based approach ISO 14971:2019, on the ISO 10993-1 and ISO 10993-18 standards. It will be helpful for Quality and Regulatory people who are involved in preparing Technical files and Design Dossiers and gives a hands-on knowledge of biocompatibility assessment, testing strategy and risk assessment approach.
https://www.dnv.dk/training/introduction-to-biocompatibility-for-medical-devices-237892
This only adds the event to your calendar, please remember to register for this event.
false YYYY/MM/DD akeGphYOczrmtQTfhmEQ22349

Varighed:

Duration: 1 day

Pris:

Course fee: DKK 6.800 excl. VAT.

Yderligere information:

You can find our cancellation policy, terms & conditions and practical information about the course here: www.dnv.dk/betingelser

About Introduction to biocompatibility for medical devices

Why this course:

The focus on biocompatibility has become stronger as the ISO standards are updated and the MDR is now in place. This course will give you an introduction and also give a route, the Biological Evaluation Plan, as to how to work with this task both from an ISO 10993-1 level and the MDR 2017/745 level. Chemical characterization is mandatory and we will go through this in more detail. 

Who should attend:

QA/RA, D&D, Clinical as well as suppliers of raw material.

What will you learn:

In this one day’ training you will get an overview of the requirements and the guidance documents in order for you to be able to establish a well-prepared Biological Evaluation Plan.

Content:

Module 1 (1 day) – Introduction to biocompatibility for medical devices with a risk-based approach:

  • ISO 10993-1 and ISO 14971
  • Biological Evaluation plan and MDR GSPR §10
  • US/FDA status
  • Raw materials, suppliers and manufacturers with respect to process aids and change control
  • ISO 10993-18 – what testing scenario to choose and why
  • Requirements on the test houses

Trainers:

The course is tutored by the below experienced trainers:

  • Anette Sjögren, MSc Biomedicine, Regulatory expert, 35 years in industry medical devices and pharmaceuticals, member of the international standardization work within medical devices.
  • Charlotte Trotzig, PhD polymer chemistry, Biocompatibility expert, 25 years in industry and member of the ISO 10993 working group.

Are you looking for a customised course?:

Content of the course can be changed and modified depending on the need of the customer for private/inhouse courses.

Please contact us for more information.

Interne kurser for din virksomhed

Kontakt os