FREE Taster Class - ISO 14971 Risk Management for Medical Device

by Semoegy MedTech Learning - Limited Seats. Attendance on a first-come-first-serve basis.

LIMITED SEATS. Attendance on a first-com-first-serve basis.

This is a 2 to 3-hour FREE excerpt of the interactive 1-Day workshop on medical device risk management in accordance with the requirements of ISO 14971.


Performing risk management is a regulatory obligation and is the underpinning tool for assessing medical device safety. Risk management is part of the design input requirements during product design & development. This means that risk control and hazard reduction measures must be included as key considerations in the final medical device design, as well as in verification and validation studies. Risk evaluation should occur continuously throughout the production and post-production processes.

This course offers a systematic methodology to performing risk management using medical device examples. It also provides guidelines on how to conduct productive meetings to construct medical device risk profiles.


1. Overview of the ISO14971 medical device risk management process

2. Roles & responsibilities in a risk management team

3. Constructing a risk management plan

4. Applying the FMEA and 5x5 matrix in risk analysis

5. Relationship between risk evaluation, risk control and medical device testing

6. Iteration of the risk management process to evaluate residual risks

7. Overview of the risk management file

8. Dealing with unforeseeable risks in risk evaluation


Dr. Nealda Yusof has experience in the medical device sector spanning more than 14 years. She was part of the pioneer medical device team at the Health Sciences Authority of Singapore as a regulatory professional from 2001 to 2003. In the next 7 years thereafter, she worked as a private consultant specialising primarily in medical device testing & data analysis, protocol development, manufacturing process validation, risk evaluation, complaints investigation, recall crisis management, process change validation and establishment of corrective & preventive actions. During that time, she played a key advisory & leadership role steering medical device design & development as well as process development teams for a multinational renal care group. Her work heavily involved onsite troubleshooting at manufacturing sites in Asia, Europe and the Middle East.

Dr. Nealda Yusof obtained her Doctor of Philosophy (Ph.D.) in Materials Science from the National University of Singapore, and a Bachelor of Laws (LLB) with Honours from the University of Birmingham in the United Kingdom.


E-mail: global.training@semoegy.com

Event Timeline
Thu Aug 20, 2015
2:00 PM - 5:00 PM SGT
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Devan Nair Institute
FREE Taster ISO 14971 Risk Management Class
Venue Address
80 Jurong East Street 21, Singapore 609607 Singapore
Walking to the campus: Take J-Walk via Jurong East MRT Exit [D], through Westgate and Ng Teng Fong Hospital
Nealda Yusof