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 …
Understanding and Analyzing Financial Statements
Onboarding is Not Orientation: How to Improve Your New Hire…
Managing Toxic & Other Employees Who have Attitude Issues
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Excel & ChatGPT Synergy Masterclass: Unleashing Financial A…
Introduction to Microsoft Power BI Dashboards
Drive Recruiting Success with the Using Recruiting Metrics …
2025 EEOC & Employers: Investigating Claims of Harassment …
Impact Assessments For Supplier Change Notices
Mastering Job Descriptions: Legal and Practical Insights fo…
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
What is in Store for Employers When Updating Employee Handb…
Designing Employee Experiences to Build a Culture of Compli…
Onboarding Best Practices for 2025: Proven Strategies to Po…
Accounting For Non Accountants : Debit, Credits And Financi…
Creating a Successful Job Rotation Program
The Anti-Kickback Statute: Enforcement and Recent Updates
FDA Compliance And Laboratory Computer System Validation
How To Create Psychological Safety in your Organization
Aligning Your HR Strategy with Your Business Strategy
Transforming Anger And Conflict Into Collaborative Problem …
How to Give Corrective Feedback: The CARE Model - Eliminati…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Zero Acceptance Sampling to Reduce Inspection Costs
Identifying, Managing, and Retaining High Potential Employe…
AI at Your Service: Enhancing Your Microsoft OfficeSkills w…
Why EBITDA Doesn't Spell Cash Flow and What Does
FDA Recommendations for Artificial Intelligence/Machine Lea…
Project Management for Non-Project Managers - How to commun…
Dealing With Difficult People In Life & Work
Developing and Implementing Quality Culture in the Organiza…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Enhancing Pivot Tables with Images: Visualize Your Data Lik…
How to Write Effective Audit Observations: The Principles f…
How to Write Contracts for Procurement Professionals
Uplifting the Credibility of HR: How to Build the Credibili…
Strategic Interviewing & Selection: Getting the Right Talen…
Performance of Root Cause Analysis, CAPA, and Effectiveness…
FDA Audit Best Practices - Do's and Don'ts
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
Excel Lookup Functions: VLOOKUP, HLOOKUP, and XLOOKUP Made …