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How to Implement MDSAP-Requirements into your ISO 13485


Overview: 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 should you Attend:
Your implementation time should be short and need smart ideas to reach the right level to pass the MDSAP - Audit by your audit organization.

Areas Covered in the Session:
Which Companies must have MDSAP?
Which Companies should have MDSAP?
Which Companies should postpone MDSAP?
What are the requirements of MDSAP?

Who Will Benefit:
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

Speaker Profile:
Prof. 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.

Event Fee: One Dial-in One Attendee Price: US $150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

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