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 …
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Leadership: Strategic Planning and Decision Making
4-Hour Virtual Seminar on Transformational Leadership - The…
Workplace Investigations 101: How to Conduct your Investiga…
Copilot and HR: An Introduction for HR Professionals
Negotiating Skills For Professional Results - Winning Strat…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Managing Complex Projects - Project Management
Managing Toxic Employees: Strategies For Leaders To Effecti…
Excel Power Skills: Master Functions, Formulas, and Macros …
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Do's and Don'ts of Giving Effective Feedback for Performanc…
Using High-Performance Coaching for Managers to Address Per…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
Understanding Artificial Intelligence (AI) & using Chat GPT
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Creating Your 2025 Marketing Strategy
Enhance Your Confidence and Leadership Presence
Trust in Leadership: Building and Maintaining Trust as a Le…
Effective Communication Skills It’s Not What You Say, But H…
2026 Handbook Overhaul: Navigating Critical Updates! Does t…
From Concept to Creation: Strategies for Cultivating Workpl…
Mastering Performance Management: Strategies for Continuous…
2025 EEOC & Employers: Investigating Claims of Harassment …
Project Management for administrative professionals
The Importance of the first 5 seconds when presenting
How to Reduce Human Error in a GMP Manufacturing Floor
Trump’s Executive Orders on DEI and Disparate Impact, and t…
How Accountants Can Use Chat GPT Effectively
Changing Behavior: Why Rewards and Punishments Often Aren't…
Pivot tables beginner to advanced + 20 advanced Pivot table…
The OBBBA Era & Beyond: Your 2025 Playbook for Compliance a…
Managing Toxic & Other Employees Who Have Attitude Issues
ChatGPT Unlocked: A Beginner’s Guide to AI and ChatGPT
Employee Handbooks: 2025 Critical Issues