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 …
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Paying and Receiving Payments for Referrals: You Can Go to …
Tattoos, hijabs, piercings, and pink hair: The challenges …
Ten Red Flags that Signal Financial Distress in Business Cu…
Excel + AI: The Smart User's Guide to Faster, Easier Work w…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
The Importance of the first 5 seconds when presenting
The New W4 - How to Assist Employees with Proper Completion…
Transforming Anger And Conflict Into Collaborative Problem …
4-Hour Virtual Seminar on Management Skills For New Managers
Microsoft Excel PivotTables: Basics of Data Analysis for Bu…
Supervisor Excellence: Skills to Lead High-Performing Teams
Tools for New Managers: Connecting with Employees to Optimi…
Fatal Errors Employers Make When Updating Employee Handbook…
The Manager’s Playbook for Leading After Layoffs: Quickly R…
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
Thriving in a Hybrid Workplace: Keys to Leadership and Team…
Excel - Lists and Tables - A Beginner's Guide to Managing L…
Launch Your Career: The Ultimate Guide for Emerging Profess…
Mastering Performance Management: Strategies for Continuous…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Strategic ways to build your professional brand
Rewiring Your Emotional Triggers: Leading with Clarity and …
AI Fundamentals for All Leaders and Managers: How to Work S…
The $1M Mistake: EEOC Discrimination Claims Employers Make …
ChatGPT Jumpstart From intro to Download to Personal Assist…
Using Claude in Excel for Productivity, Automation & Data A…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Why EBITDA Doesn't Spell Cash Flow and What Does?
HIPAA Compliance in 2026 — Practical Strategies for Breach …
FDA Regulation of Artificial Intelligence/ Machine Learning
How to Write Procedures to Avoid Human Errors
Secrets Of Psychology - Why People Do The Things They Do
AI in B2B Marketing: What Your Compliance Team Needs to Know