Design Control for Medical Devices

Since 1984 the FDA has identified the lack of proper design controls as one of the major reasons for device recalls.

This was the reason FDA formalized the legal requirement for design controls in the Medical Device Amendments of 1996. Device experts have estimated it cost 10 times more resources to correct a poor design after it has been in manufacture than to design it right to begin with.

This is in addition to the bad publicity of recalls and other regulatory action. This webinar will emphasize key portions of good design control and poor design control along with some important tools learned by the author over the last 25 years.

Why you should Attend: Design control has been a legal requirement for over 30 years, yet many firms fail to take full advantage of a controlled method for introducing new products or changing existing products costing millions of dollars and injuring both patients and health care professionals.

A sound design control system will help avoid:

• Recalls resulting from improper design
• Problems from improper design control resulting in loss of CE marking
• Class action lawsuits for shipping poorly designed devices
• Expensive post market repairs & warranty costs

• FDA's design regulations
• International design control requirements
• Design plans
• Verification vs. Validation
• Risk Management
• International standards
• FDA guidance documents

• R&D Personnel
• Design Engineers
• Validation Engineers
• Regulatory Professionals
• Marketing managers
• QA & RA Managers