ISO 13485:2016 - What are the hot topics and changes?
- Duration: 90 Min
Why Should You Attend:
The ISO 13485:2016 is the essential standard for quality management systems for medical device manufacturer, importer, distributors and dealers in Europe and in the international markets. This standard has received some changes e.g. responsibility of outsourced processes, computer system validation, control of nonforming products etc. The understanding of this changes and how to implement last minute changes until March 2019 is essential to keep the certificates valid after March 2019.
- Introduction and who should apply the ISO 13485:2016
- Overview about the changes of the ISO 13485:2016
- Explaining of each change
- Smart and fast ways to implement the changes in your quality management system
- Fast track internal audit to approve the changes
Attend this webinar to understand, what are the changes to the previous standard and how to implement the changes in your current quality management system in a simple and quick way. Your implementation time until March 2019 is short and need smart ideas to reach the right level to pass the quality management audit by your certification company.
Areas Covered in the Webinar:
- Closer regulatory binding of the ISO to the new EU MDR
- Adjustments in the management review
- Responsibilities for outsourced processes
- Labeling, UDI
- Changes in the control of nonconforming products
- How to deal with ISO 9001 or any other quality management system in multidisciplinary quality management systems
Who Will Benefit:
CEO's, Quality/Regulatory affairs manager and quality representatives of medical device manufacturer, importer, distributors and dealers who work with Europe or countries, which require ISO 13485.
Instructor Profile:
Frank Stein
Senior Expert Medical Devices, Frank Stein healthcare projects
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.
More Trainings by Expert
Supplier Management with the new Medical Device Regulation EU MDR 745/2017
Refund Policy
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Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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