This course will give an introduction into the Medical Device Single Audit Program (MDSAP). The introduction will give an overview about the program definition, the requirements for the quality management system, how a smart implementation of these requirements in the quality management system is possible and finally how the audit for five countries (Australia, Brazil, Canada, Japan, US) is working.
Why You should Attend:
You should attend this seminar to understand, what is MDSAP and how is MDSAP working. Your implementation time should be short and need smart ideas to reach the right level to pass the MDSAP - Audit by your audit organization.
This webinar will give you a clear structured overview and introduction, how to apply MDSAP-Requirements and how to implement the requirements into your quality management system. First you learn to identify the relevant requirements, second you learn how to implement the identified requirements into your quality management system based on ISO 13485:2016 or 21 CFR 820. The course based on the MDSAP Companion-Document, issued by the FDA
Areas Covered in the Session:
- 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 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?
Who will benefit:
- Medical Device Manufacturers who develop, manufact and / or sell to US, CAN, BR, AUS, JP. Those in the following roles will benefit
- CEOs
- Regulatory Affairs Managers
- Quality Managers
- Quality Representatives
- Other managers who need to deal with regulatory or quality guidelines
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- Certification
November 13, 2020 (10:00 AM - 6:00 PM EST)
Areas Covered in the Seminar:
- 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 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?
Prof. Dr. h.c. Frank Stein
Senior Medical Device Expert, Nemius Consulting GmbH
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.
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