ISO 14971:2019 Risk Management for Medical Devices

Deskripsi

This two days intensive course enables greater understanding of the impact that ISO  14971:2019 has on the decision-making process when manufacturing medical devices. It helps medical device professionals understand how ISO 14971:2019 can improve their business and risk management efforts.

This course is designed to provide you with 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 links with the ISO 13485:2016 standard and the MDR 2017/745.

Practical activities throughout the day will give you the opportunity to apply your skills, implementing risk management activities so that these can be embedded within the organization on completion of the course.

Participants

This course is ideal for you if you’re in a QA/Regulatory/Engineering/Manufacturing role involved in  medical device design, development and manufacturing.

Prerequisites
You should have experience with, or basic knowledge of, quality management systems for the medical device industry. We recommend you have a basic awareness of medical device development, quality assurance and ISO 13485:2016.

MATERI

Upon completion of this training, you will be able 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 and IVDR 2017/746

METODE PELATIHAN

Pre test

Presentation

Discussion

Case Study

Post test

Evaluation

FASILITAS

Handout

Certificate

Training Kit

Lunch and Coffee Break

Souvenir.

Form Pre-Registrasi

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