ISO 13485:2016 - What are the hot topics and changes?

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. The major change is the interface to the regulatory requirements, which mean for Europe you need to change and add a Post-Market-Surveillance Process with reporting to the authorities and notified bodies, a Post-Market-Clinical-Follow-Up-Process, to update your vigilance process, an update for the technical documentation process and to update the contracts with suppliers and distributors to fulfill the EU MDR changes starting in May 2020.Your implementation time until May 2020 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.

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.

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