ComplianceOnline, Zurich
2019-03-07
Attend this seminar to learn medical device quality management standard ISO 13485. It will cover 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 is working. Learning Objectives: - What are the requirements of ISO 13485?
- Which Companies must apply ISO 13485?
- How to implement ISO 13485 in a smart way into a medical device quality management system?
- How the ISO 13485-Audit is working?
Who will Benefit:- CEO’s
- Regulatory Affairs
- Quality Managers
- Quality Assurance
- Other managers, which need to deal with regulatory or quality guidelines
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Invited Speakers:
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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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