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Audio conference highlights

Managing risk has always been an integral part of medical device development, but is now becoming more integrated with quality management systems. Previous experience with “risk assessment” had been the application of risk analysis to determine specific risks associated with a device. This is no longer the case with a quality management system such as ISO 13485 and the recently updated ISO 14971 standard defining and clarifying the risk management process.

This presentation helps organizations to better understand how risk management can reach its full potential as a management tool. When there are complaints or adverse events for a product family, have these been addressed in the risk analysis? When does the risk management file get updated or reviewed? How does an organization go about creating a system to assure that risk management fulfills that role within the product life cycle? These questions will be answered as the speaker walks attendees through the process of implementing a risk management system within a medical device company.

This audio conference covers:

• Applying the ISO 14971 standard to medical devices and IVDs
• Incorporating risk management into an ISO 13485 system
• Reviewing risk management as part of the management review process
• Risk management principles, and the difference between risk management and risk analysis
• Contents required for the risk management file

About the speaker:

Richard A. Vincins is part of the Emergo Group as Senior Consultant responsible for quality assurance and regulatory affairs activities. In this role he is responsible for the implementation of quality systems, conducting internal audits, and providing regulatory expertise in national and international regulations. He brings 18 years of experience in the medical industry including worldwide regulatory compliance efforts for IVD, medical device, and pharmaceutical companies. His work experience at companies like Medtronic and bioMerieux include establishing quality systems to ISO standards and CE marking of multiple product lines. Vincins is an ASQ Certified Quality Auditor and holds a Regulatory Affairs Certification for U.S. Regulations and European Union Regulations through the Regulatory Affairs Professional Society. Richard graduated from Bridgewater State College, MA, with a bachelor's degree in biomedical biology.

Who should attend?

• Manager / Director / VP Quality Assurance
• Manager / Director / VP Regulatory Affairs
• Engineering / R&D
• Documentation
• Health & Safety
• Customer Relations
• Senior Management

This audio conference is rated General Interest.

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.