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 …
Controller Challenges in Changing Times: New Roles as Strat…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Stress, Change And Team Resilience Through Humor: An Intera…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
How to Prepare For and Host a FDA Inspection and Respond to…
Sunshine Act Reporting - Clarification for Clinical Research
The Importance of the first 5 seconds when presenting
From Chaos To Calm: How to Eliminate Drama and Boost Workpl…
Complaint Handling and Management: From Receipt to Trending
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Managing Toxic Employees: Strategies For Leaders To Effecti…
ChatGPT Unlocked: A Beginner’s Guide to AI and ChatGPT
Understanding Artificial Intelligence (AI) and the Incredib…
6-Hour Virtual Boot Camp on Microsoft Power BI
Onboarding is NOT Orientation - How to Improve the New Empl…
The Monte Carlo Simulations in Excel for Risky Investments
ChatGPT and Project Management: Leveraging AI for Project M…
Project Management for administrative professionals
Workplace Investigations 101: How to Conduct your Investiga…
Transform Data into Insights: A Beginners Guide to Excel Pi…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Construction Lending And Real Credit Administration: Evalua…
Dealing With Difficult People: At Work & In Life
Understanding Accounting for non - Accounting professionals
New Form 1099 Reporting Requirements: 2025 Compliance Update
Human Error Reduction Techniques for Floor Supervisors
HR Metrics and Analytics 2025 - Update on Strategic Plannin…
7 Ways To Beat Burnout: Without Quitting Your Job
Treating Employees Like Adults: Discipline versus Empowerme…
Understanding EBITDA – Definition, Formula & Calculation
Ethical Terminations: Navigating Employee Exits with Legal …
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
How to Write Procedures to Avoid Human Errors
FDA Proposes Framework to Advance Credibility of AI Models
Project Management for Non-Project Managers - Scheduling yo…
Validation Statistics for Non-Statisticians
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
4-Hour Virtual Seminar on Hidden Secrets of Selling & Marke…
The Alphabet Soup: When the FMLA, ADA, COBRA, and Workers' …
Talent Management: How to Leverage AI and ChatGPT Tools for…
Offboarding with Care: Conducting Legal & Ethical Employee …
2-Hour Virtual Seminar on How to Conduct an Internal Harass…