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 …
Strategies For Job Seekers: Best Practices For A Strategic …
Dealing With Difficult People: At Work & In Life
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
The Perfect Storm Coming to Healthcare: Value Based Care Me…
Excel - Reporting Simplified - Learn Pivot Tables from Scra…
Turning Workplace Conflict into Positive Connection
Retention Starts Here: Stop Losing Your Critical Talent and…
Project Management for Non-Project Managers - How to commun…
The Business Case for LGBTQIA+ Inclusion in the Workplace: …
AI and Human Resources: The Great Opportunity!
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
AI-Powered Change Leadership Operationalizing AI: Practical…
Cyber Security Incident Response Team Training Program
Excel Power Skills: Master Functions, Formulas, and Macros …
Transforming Anger And Conflict Into Collaborative Problem …
The Courage to Speak: Overcoming Fear and Owning the Room
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Finance & Accounting 101 Simplified
6-Hour Virtual Boot Camp on Microsoft Power BI
Developing an Agile Workforce with Emotional Intelligence (…
Compliance Under Fire: Navigating I9 Immigration Raids & …
FDA Regulation of Artificial Intelligence/ Machine Learning
Empowering Conflict Resolution: Letting Go to Gain Control
Human Error Reduction Techniques for Floor Supervisors
How to Give Corrective Feedback: The C.A.R.E. Model - Elimi…
Secrets Of Psychology - Why People Do The Things They Do
How To Conduct An Internal Harassment And Bullying Investig…
Leadership: Strategic Planning and Decision Making
Marketing to Medicare or Medicaid Beneficiaries - What You …
Polish your Presence on Linkedin - The Powerful Profile
Utilizing A Proven Process When Conducting Sensitive, Inter…
Bootcamp for New Managers and Supervisors: Develop These Es…
Leveraging Artificial Intelligence in HR