Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment.
Like any process that tries to produce repeatable and consistent results, the risk management process must be clearly understood, including the strengths but also the limitations.
By attending this seminar you will learn the main elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2, risk management life cycle steps and benefits, and FDA software reviewers' guidance.
Upon completing this course participants should:
- Understand the risk management process, the activities, and deliverables as well as the organization framework necessary
- Be able to Interpret and discuss the requirements of ISO 14971
- Develop a risk analysis framework document
- Be able to conduct risk analysis team meetings
- Recognize how and where to use the various techniques during the design life cycle.
- Understand how to apply ISO 14971 into development process
- Know how to document your Risk Management
- Explain how your Risk Management system fits into quality system and business practices.
- Perform risk assessments effectively
Who Will Benefit:
This course is relevant to managers, supervisors, QA / RA, and design/system engineers. Even experienced personnel will benefit from the "across industry" perspective and the illustration of standard practices that only a presenter with extensive experience in more than 100 projects can provide. Specific positions that would benefit are:
- Senior Quality Managers
- Quality Professionals
- Regulatory Professionals
- Compliance Professionals
- Project managers
- Risk managers
- Engineering management
- Quality Assurance personnel
- System and design engineers
- Software Engineers
- Usability Engineers
- Verification / validation personnel
- Production Managers
- Quality Engineers
- Quality Auditors
- Medical Affairs Professionals
Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. Mr. Weber graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, he has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices.
In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. He has helped multiple companies, from startups to Fortune 500 firms.