This Webinar will outline the basics of design control for medical devices and the device part of a combination product. Failure to develop these products under design control may result in a product that is not suited for the intended market or failure of approval to market from regulatory agencies.
This Webinar will outline the basics of design control for medical devices and the device part of a combination product. The webinar will cover the basics of design control and the overall flow of the design control process. It will also cover the aspects of inputs into the design control process (design inputs) and how inputs are key to the entire process. Understanding the process of design control is essential for the successful development of medical devices as well as a regulatory requirement.
This Webinar will outline the basics of design control for medical devices and the device part of a combination product. The webinar will cover the basics of design control and the overall flow of the design control process. It will also cover the aspects of inputs into the design control process (design inputs) and how inputs are key to the entire process. Understanding the process of design control is essential for the successful development of medical devices as well as a regulatory requirement.
Alan M Golden
Alan M Golden has over 30 years of experience in the medical device industry, both in basic research and 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 wherein 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 …
6-Hour Virtual Boot Camp on Microsoft Power BI
2-Hour Virtual Seminar on Empowering Presentations with Pow…
Motivated to Stay: Effective and Best Practice Retention Me…
2-Hour Virtual Seminar on The Complexity and Interplay Amon…
The Anti-Kickback Statute: Enforcement and Recent Updates
Mindful Communication:The Key to Meaningful Conversations i…
Managing Toxic & Other Employees Who Have Attitude Issues
How to Give Corrective Feedback: The C.A.R.E. Model - Elimi…
Employee Handbooks: 2025 Critical Issues
Accounting For Non Accountants : Debit, Credits And Financi…
ChatGPT and Project Management: Leveraging AI for Project M…
50+ new Excel features so far this decade
2025 EEOC & Employers: Investigating Claims of Harassment …
Why EBITDA Doesn't Spell Cash Flow and What Does?
Retaining Talent in the Age of Employee Shortages
Succession Planning Simplified: Fast-track Your Future Lead…
Workplace Compliance in 2025: New Laws, Big Changes, and Wh…
How to Write Contracts for Procurement Professionals
Leverage AI & ChatGPT for Talent Acquisition: Best Practice…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Female to Female Hostility @Workplace: All you Need to Know
Leadership: Strategic Planning and Decision Making