Get 50% off with the coupon code COUPON50Design Control for Medical Devices and Combination Products
- Thursday
- June
- 12
- 2025
Alan M Golden Overview:
This webinar will cover the basics of design control as applied to medical devices or combination products which include a medical device. The regulatory requirements for medical device design control will be covered including FDA and ISO requirements. The basic flow of design control will be explained as well as the necessary trace from design inputs to outputs. Emphasis will be placed on the concept of user needs and product requirements development as part of design control.
Why you should Attend:
An understanding of design control is crucial to the development and support of regulated medical devices and combination products which contain a medical device. Not only is the application of design control concepts required by regulatory agencies, but proper application of design controls will help ensure a properly designed and well-made product will be produced.
Areas Covered in the Session:
- The need for design controls
- Overview of design control flow
- Regulatory requirements
- Design inputs: User need
- Examples of user needs
- Design inputs: Product requirements
- Examples of product requirements
- User needs to product requirements trace
Who Will Benefit:
The following professionals in the Pharmaceutical, Medical Device, or Combination Product industries with responsibilities in the following areas:
- Quality Systems
- Supplier Quality
- Quality Assurance
- Quality Control
- Change Control
- Engineering/R&D
- Regulatory Affairs
- Manufacturing
Speaker Profile
Alan M Golden has over 35 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.
Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 20 years.
Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.
Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.