The New ISO 14971 - How to Create a Risk File for Medical Devices
Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.
This course will give an introduction into the new ISO 14971 and how to create a risk management file according to the ISO 14971. The course will give you an overview of the requirements and how a smart implementation of these requirements in your product documentation is possible and finally what are the expectations of the European Notified Bodies.
- What is the Medical Device Single Audit Program (MDSAP)?
- Which Companies must have MDSAP?
- Which Companies should have MDSAP?
- Which Companies should postpone MDSAP?
- What are the requirements of MDSAP?
- How to implement MDSAP in a smart way into an quality management system according to ISO 13485, 21 CFR 820 (QSR) or any other regulatory framework?
- How the MDSAP-Audit is working?
- What is the difference between MDSAP and European Notified Body Audits?
Course Level - This webinar is on an Advanced – Intermediate Level
Who Should Attend
- CEO’s of companies, which sell to Australia, Brazil, Canada, Japan or US
- Regulatory Affairs Managers of Companies, which sell to Australia, Brazil, Canada, Japan or US
- Quality Managers of Companies, which sell to to Australia, Brazil, Canada, Japan or US
- Quality Representatives of Companies, which sell to Australia, Brazil, Canada, Japan or US
- Other managers, which need to deal with regulatory or quality guidelines
Why Should You Attend
You should attend this webinar to understand, what is the ISO 14971 and how is the ISO 14971 working. Your implementation time should be short and need smart ideas to reach the right level of a risk management file according ISO 14971.