ISO 14971 Medical Device Risk Management Training
Instructor:
Frank Stein
Product ID: 706564
Training Level: Intermediate to Advanced
- Duration: 3 hrs
Why Should You Attend:
You should attend this webinar to understand, what are the changes to the previous ISO 14971 and how to implement the changes in your risk management file in a simple and quick way. Your implementation time can be shorter with a good plan and approach and need smart ideas to reach the right level to pass the expectation by your certification company or notified body.
Learning Objectives:
In this course, you will:
- Learn Who must apply the new ISO 14971:2019 requirements
- Get an overview about the changes of the ISO 14971:2019 regarding technical documentation processes and product life cycle management
- Learn What are the interfaces between the ISO 14971:2019 and the EU MDR 2017
- Smart and fast ways to implement the changes in your technical documentation and risk management file.
Areas Covered in the Webinar:
- The Scope of the ISO 14971:2019
- The interfaces to the EU MDR 2017/745
- New and updated processes required by the ISO 14971:2019
- How to implement the required changes and how to update the risk management file?
Who Will Benefit:
Product manager, quality/ regulatory / medical affairs manager, quality representatives of
- medical device manufacturer,
- medical device OEM/PLM
- EU Representatives
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 Training By Experts
- Supplier Evaluation and Internal Auditing for FDA and ISO 13485 Compliance: Pack of Three Courses
- ISO 13485:2016 - What are the hot topics and changes?
- Supplier Management with the new Medical Device Regulation EU MDR 745/2017
- Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017
- Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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).
