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.
WHY SHOULD YOU ATTEND?
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.
AREA COVERED
- Overview of design control
- Need for design controls in device design
- Regulatory requirements
- Design inputs: User Needs
- Design inputs: Product Requirements
- Next steps in design inputs
LEARNING OBJECTIVES
- Understand the need for design control in product development
- Understand the regulatory requirements from both the FDA and CE mark perspectives
- Learn the flow of design control
- Understand user needs, the start of design control
- Understand the translation of user needs to product requirements
- Next steps
WHO WILL BENEFIT?
- Quality professionals
- Regulatory Affairs Professionals
- R&D Scientists
- Production Personnel and Technical Support Personnel.
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.
- Overview of design control
- Need for design controls in device design
- Regulatory requirements
- Design inputs: User Needs
- Design inputs: Product Requirements
- Next steps in design inputs
- Understand the need for design control in product development
- Understand the regulatory requirements from both the FDA and CE mark perspectives
- Learn the flow of design control
- Understand user needs, the start of design control
- Understand the translation of user needs to product requirements
- Next steps
- Quality professionals
- Regulatory Affairs Professionals
- R&D Scientists
- Production Personnel and Technical Support Personnel.
Speaker Profile
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 …
Upcoming Webinars
Managing Difficult Employee Conversations
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Dealing With Difficult People In Life & Work
Predictive Accounting: Driver-Based Budgeting And Rolling F…
Pay Equity Changes for 2024! What Employers Need to Know to…
Leader Branding: How to Communicate with Confidence to Attr…
Project Management for Non-Project Managers - How to commun…
Design Verification, Validation and Testing for Medical Dev…
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Why EBITDA Doesn't Spell Cash Flow and What Does
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Employee or Independent Contractor – U.S DOL Announces 2024…
How to Survive an Emotionally Toxic Workplace
Best Practices in Complaint Management for Regulatory Compl…
Human Factors Usability Studies Following ISO 62366 and FDA…
Ensuring Safe and Effective Pharmaceutical Products: A Comp…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Updated Metro 2®, e-OSCAR and the New Tougher FCRA/CFPB Com…
Embracing Diversity and Inclusion in Talent Acquisition
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Understanding and Analyzing Financial Statements
Divorce, Adoption and Other Special Tax Topics
Design History File (DHF), the Device Master Record (DMR) a…
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Setting up Quality System for FDA Regulated Products: Tips …
Is Your Culture Working For or Against Your Success? If You…
Marketing to Medicare or Medicaid Beneficiaries - What You …
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
Sunshine Act Reporting - Clarification for Clinical Research
Documenting Misconduct that Will Stand Up in Court
Stress, Change And Team Resilience Through Humor: An Intera…
FDA Regulation of Artificial Intelligence/ Machine Learning
Managing Toxic & Other Employees Who have Attitude Issues
Excel - Lists and Tables - A Beginner's Guide to Managing L…
Pharma 4.0: Next Generation Technology Approach to GxP Prod…
Patient Gifts, Discounts and Freebies: What You Can and Can…
Managing Complex Projects - Project Management
All About Civility - Eliminating a Culture of Gossip Rumors…
From Challenges to Compliance: Understanding Dietary Supple…
Improving Employee Engagement & Retention Through Stay Inte…
How To Conduct An Internal Harassment And Bullying Investig…