DURATA e MODALITA

Durata: 8(h)

Modalità:

Webinar 1to1 on Demand o piccoli gruppi

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Description:

This course is designed to provide an understanding of ISO 14971: 2019 and the impact it has on the design, development, manufacturing and lifecycle of medical devices. It will also provide medical device manufacturers with knowledge of how ISO 14971: 2019 relates to ISO 13485: 2016 and MDR 2017/745.

LEVEL: MEDIUM

The course aims to:

• Define risk management terminology
• Explain how risk management relates to the product lifecycle
• Outline the stages of the risk management process
• Define the key deliverables of the risk management process
• Apply risk management principles within your organization
• Identify the links between ISO 14971:2019, ISO 13485:2016, MDR 2017/745

Who Will Benefit:

Our online course is aimed at, among others, regulatory personnel, managers, CEOs, CFOs, employees of the in vitro diagnostic medical device industry and users of in vitro diagnostic medical devices who wish to learn about the new regulation:

• Quality Manager
• Quality Engineers
• Design Quality
• Regulatory Affairs specialist
• Medical Affairs specialist
• Clinical Affair specialist
• R&D Engineers
• Marketing

Certification Requirements:

Students must view the entire program and successfully pass an online, multiple choice final assessment with >80% passing grade. Certificate will be printable in PDF format immediately after satisfying requirements.

Online Training Programs Includes:

• Answer to questions submitted during the webinar.
• An online final assessment with multiple choice questions.
• A Certificate of Completion.

Corso Hosted by Dr. Ing. Gianluca Tordi

I’m a Biomedical Engineer with long experience in the consulting fields. I worked in several project for Osteosynthesis, Endoscopic, Combination Device, Bone Substitutes, Software as Medical Device with different roles and responsibilities from R&D to Regulatory, Quality and Process Validation.
I’ve supported companies ranging from innovative start-up (so developing at the same time the product and the process to realize and control it) to mid-size companies and bluechips (so focusing on details and worldwide regulatory compliance challenges) in the field of medical device and pharma. TS Q&E is a ISO 13485:2016 certified consulting service provider, that can support as external partner, take ownership of some part of the project or deliver full projects.