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 …
Transform Data into Insights: A Beginners Guide to Excel Pi…
Leadership: Strategic Planning and Decision Making
Onboarding Best Practices for 2025: Proven Strategies to Po…
Seeking Truth: Detecting Truth, Lies and Deception in a Wor…
Managing Difficult Employee Conversations
Copilot and HR: An Introduction for HR Professionals
How to Document Employee Discussions and Why it is Important
Dealing With Difficult People In Life & Work
How to Write Effective Audit Observations: The Principles f…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
FDA Compliance And Laboratory Computer System Validation
4-Hour Virtual Seminar on Transformational Leadership - The…
3-Hour Virtual Boot Camp on Easier Excel Automation with VB…
2025 Handbook Overhaul: Navigating Critical Updates! Federa…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Negotiating Skills For Professional Results - Winning Strat…
Building Thriving Teams: Proactive Strategies for Managers …
Designing Employee Experiences to Build a Culture of Compli…
Empowering Conflict Resolution: Letting Go to Gain Control
Navigating Alcohol and Drug Addiction Protections Under the…
President Trumps Executive Orders And What They Mean to Emp…
The Anti-Kickback Statute: 2025 - Year in Review
FDA Technology Modernization Action Plan (TMAP) and Impact …
Form W-9 Compliance: TIN Verification, B Notices, and Avoid…
Workplace Investigations 101: How to Conduct your Investiga…
50+ new Excel features so far this decade
FDA Regulation of Artificial Intelligence/ Machine Learning
From Challenges to Compliance: Understanding Dietary Supple…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
The Importance of the first 5 seconds when presenting
Why EBITDA Doesn't Spell Cash Flow and What Does
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…
Impact Assessments For Supplier Change Notices
The Monte Carlo Simulations in Excel for Risky Investments
Understanding the incredible uses and fallbacks of ChatGPT
California Meal and Rest Breaks: What You Don't Know Can Co…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Onboarding is NOT Orientation - How to Improve the New Empl…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Female to Female Hostility @Workplace: All you Need to Know
6-Hour Virtual Seminar on Learning the Highlights of Excel …