Conference Q&A: Medical Device Risk Management A to Z

Conference Q&A: Medical Device Risk Management A to Z

Compliance Online are hosting a two-day seminar entitled ‘15th to the 16th of December in Salt Lake City, Utah.

Designed specifically for manufacturing professionals, participants will learn how to apply good risk management principles to medical products manufacturing operations such as medical devices, combination products, and pharmaceuticals.

Q1 - What is the focus of this seminar and why is it being offered? What makes this seminar unique compared to others on Risk Management courses?

This seminar is unique among risk management courses as it provides the participant with a concise, yet informative summary of what is needed to successfully implement and maintain a Medical Device Risk Management Program. The course is built to accommodate the novice as well as the seasoned professional. This course has been built to explain what is required as well as why.  

This course explains how Medical Device risk management fits into the overall field of risk management and compares to related products, such as pharmaceuticals. The course also covers some elements of Combination Products. The instructor provides an opportunity for special topics to be added to the course on the second day as appropriate.

Q.2 Who should attend this seminar and what can they expect from it? What are the benefits of attending? How is the day scheduled?

This course is designed for anyone that participates in any aspect of Medical Device risk management. Professionals from Engineering, Quality Assurance, Regulatory Affairs, Medical, Operations, Materials Management, Project Management, and R&D are all going to obtain significant insights into their specific roles as well as the big picture.  

The seminar has been attended by individual contributors, supervisors, managers, Directors, and VP’s. The course is designed to follow a product through the Risk Management Process, so each module builds on the prior work.

Q.3 Who is speaking at the seminar and what is their background in the topic? What kind of insights will they provide for attendees? Why were they chosen?

The speaker is Stan Mastrangelo. Stan has over 30 years industry experience and was personally involved in the creation of ISO 14971, the international standard for Medical Device Risk Management. Additionally, Stan was involved in the development of ICH Q9 as a member of the PhRMA committee and was a member of the Work Group that created ISO 31000 that created the overarching enterprise risk management standard. No other individual participated in the creation of the Medical Device, Pharmaceutical, and Enterprise International Risk Management Standards.

Q.4 How often is this seminar held? Do you have any highlights from past conferences? What do you hope attendees will take away from this conference?

The seminar is held three times per year publicly and may be provided at your facility on an ad hoc basis upon request.  

Past conferences have been attended by professionals from a diverse group of corporations, with diverse levels of education, background, and training. This diversity is utilized to demonstrate the effectiveness of teams in decision-making and problem-solving.  

Attendees of the training have confirmed that the course provides information and insights on Medical Device risk management. Many attendees stated that they have found their most significant insights from the hands-on breakout sessions. 
         

CONCLUSION

There are a number of factors driving growth in the medical devices market, including the increasing popularity of home-use mobile medical devices and the ongoing evolution of wearables. These devices are being used to improve diagnosis and care for chronic medical conditions like cancer and cardiovascular disease.

Risk management is extremely important, and manufacturers have an obligation to analyze, assess, and mitigate any potential product issues.

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Published by Research and Markets

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