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


Instructor: Frank Stein
Product ID: 705864
Training Level: Intermediate to Advanced

  • Duration: 90 Min
In this quality management system webinar attendees will learn the recent changes to ISO 13485:2016 standard in step by step process and how to implement these changes in their current quality management system to pass the quality management audit. Also attendees will gain knowledge on how to deal with ISO 9001 or any other quality management system in multidisciplinary quality management systems.
Last Recorded Date: Jan-2019


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Read Frequently Asked Questions

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.

Instructor Profile:
Frank Stein

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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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. 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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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