Course description:

This course addresses the requirements of ISO 14155:2020 regarding management of the risks to patients due to clinical investigations. ISO 14155 makes a normative reference to ISO 14971, which binds and integrates the two standards. This course covers the risks to study subjects from both the investigational medical devices and the clinical study itself.

Intended Audience:
RM #301 is intended for people who are responsible for clinical investigations. For example, Clinical Study Directors, or principal investigators. Other functions who could also benefit from the course are: Clinical Quality, and management.

Objective:

Risk Management 301 offers knowledge on the following topics:

• Why do we need to do risk management? Regulatory basis.
• Distinction of the various risks related to clinical investigations.
• What is the relationship between ISO 14971 and IS 14155?
• Correlation of terms between ISO 14971 and ISO 14155
• When is risk management required? When is it not?
• What are the requirements for risk management?
• Information flow between ISO 14971 and ISO 14155
• What information flows from risk management to clinical documentations, e.g., IB, CIP, and ICF?
• Some fundamentals:
  • What is risk?
  • Language of risk management
• How risks are controlled
• Benefit/Risk profile
• Categorization of adverse events
• Tips and advice

Upon completion, participants should:

1) Understand the relationship between ISO 14971 and ISO 14155
2) Become aware risk management requirements for clinical investigations
3) Understand the different types of clinical investigations and when risk management is required
4) Understand how risks are controlled under the governance of both ISO 14971 and ISO 14155
5) Understand benefit/risk evaluation
6) Be able to categorize adverse events

Duration: 3:00 hours

Language of instruction: English

Means of delivery: In-person, and online via Zoom

CEU: ASQ and CSQE certified professionals can receive CEUs. Ask for a certificate of attendance.

About the Instructor

Award winning, international educator, consultant, and author

Bijan Elahi has worked in risk management for medical devices for over 30 years at the largest medical device companies in the world, as well as small startups.  He is a Technical Fellow, and the Medtronic corporate Advisor on safety risk management of medical devices.  In this capacity, he offers education and consulting on risk management to all Medtronic business units, worldwide.  Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering.  At the invitation of the FDA, he teaches a graduate course on medical device risk management at Drexel University (Philadelphia, USA).

Bijan Elahi is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 10,000 individuals worldwide with outstanding results.  Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the best-selling book: Safety Risk Management for Medical Devices, published by Elsevier publishing.