Bringing Compliance to Design Control through Life Cycle Management of Older Medical Devices and Surgical Instruments

Many regulated companies have not brought their old products up to the new ISO Standards and FDA Regulations and are not in compliance. All products for example should be compliant to 14971:2007 and not 14971:2000. Design History Files need to be adjusted to meet the new standards. The FDA expects that the Risk Management File be completed for every product and is updated and integrated into the company quality system. Old medical devices and surgical instruments need to have a risk management file, which includes a risk plan, risk summary report, risk and hazard analysis. It should also describe the risk acceptance criteria as well as roles and responsibilities of each member on the team.

Areas Covered in the seminar:

• Corporate and team responsibilities.
• Gathering of product data to build design history files and technical files.
• Post design issues.
• Process for gathering the proper data for compliance of products.
• Gap analysis.
• What is the risk management file and what does it include per ISO 14971:2007.
• How to document the design history file for old products through life cycle management.
• Dealing with the FDA.
• Design transfer.
• Life cycle mamagement from concept to obsolesence.
• Compliance involving life cycle management.
• Check list in phases.

Who will benefit:

This webinar will provide valuable assistance and gives a process to all regulated companies to bring their product design history files and technical files up to date with the new standards through life cycle management. The employees who will benefit include:

• End-users responsible for design control and technical files that need to be updated to the new standards
• R&D and product development engineers and managers
• Business develop and product managers
• QA, Regulatory Affairs and team members who contribute to design history or technical files.
• Product life cycle managers
• Operations managers
• Consultants

Instructor Profile:
Rob Braido, is the founder and principle of Visionary Consulting LLC, a consulting firm that specializes in project management and product transfers of medical devices, surgical instruments and drug delivery systems. The firm also assesses design control, due diligence and emerging technologies for management evaluation and remediation. Rob develops cutting edge prototype/ product development business models for pull through business for increased profit and growth. Rob has published many articles on Product Development and Leadership.