Conformance of Design History Files for Mature Medical Devices

This webinar on Design History Files (DHF) will provide a step-by-step procedure for all medical device companies that are in need of bring their product design history files up to date with the current standards.

Many medical industry companies have not brought their old product lines up to current FDA standards and are not in total compliance. This webinar defines the procedures to be followed for medical products design history file remediation.

For example, companies should be compliant to ISO 13485, ISO 14971, etc. Design History Files and validations need to be updated to meet current standards. The FDA expects continuous improvement and risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product and updated validations for product and processes. Each device needs to have a gap analysis to determine obsolescence or re-validate. It should also describe the risk acceptance criteria as well as roles and responsibilities of each member on the team.

In this webinar, we will discuss practical steps you can follow to bring your product design history files up to current standards.

Areas Covered in the Session :

• Multi-functional team approach/responsibility.
• Set procedures and template to complete remediation for design history file of old devices to meet current standards.
• Gap analysis
• Data gathering to build the design history files
• Risk procedure
• Risk assessment for prioritizing remediation
• Validations
• Dealing with the FDA
• Phase by phase check list.

Who Should Attend:

This webinar will provide valuable assistance and give a procedure to all regulated companies that need to bring their product design history files up to date with current standards. The employees who will benefit include:

• Senior management
• End-users responsible for design control and technical files that need to be updated to the current standards
• R&D and product development
• Process engineers and managers
• Operations and plant management
• Validation engineers
• Remediation teams
• Documentation teams
• QA, Regulatory Affairs
• QC and Corporate Auditors
• All team members who contribute to design history, clinical, validations or technical files
• Consultants
• All Contract Manufacturers working in the medical industry

Course Director: ROBERT BRAIDO

Robert Braido has 40 years of experience in the medical industry. He is president of Visionary Consulting LLC and has been consulting with medical OEM’s and CMOs for over 7 years. Mr. Braido’s has a broad breadth of medical industry experience in prototype/product development, global strategic/tactical planning, technical due-diligence/gap analysis for acquisitions, engineering, operations and business development. He has had great success working at Ethicon Endo-Surgery a J&J Company, Baxter Healthcare, Teleflex Medical, GW Plastics and The Tech Group with increasing responsibilities to the level of VP of Advanced Technologies. He was a member of the Board of Directors for the Society of Plastic Engineers Medical Division for over 10 years and elected Chairman of the Medical Division twice. Mr. Braido was selected as a member of a Johnson & Johnson Integration Team that took a small fledgling endoscopic medical device company with totally new products, technologies and structure from $75 million to $850 million in 5 years. His career is built on the ability to motivate, lead and coach people in different disciplines throughout the medical industry. The key factor has been driving innovation. Mr. Braido was elected, as the Consortium Chairman for the Government Reinvestment Program with MIT, the National Science Foundation and seven leading Fortune 200 companies to commercialize 3D Printing and emerging technologies in plastics and metal. He represented J&J as the principal investigator in the development of 3D Printing with the consortium. He has also been an independent reviewer for the National Science Foundation, J&J, MIT, EdgeOne Medical and others. He has published numerous technical and leadership articles and white papers. In the past he has shared his extensive experiences at seminars, workshops, technical conferences, symposiums and webinars on subjects relating to the medical and plastics industries on due-diligence/gap analysis, product development, plastic and metal manufacturing, plastic product and equipment transfers, compliance, leadership and developing an innovation culture.