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
![ins_img](/Speaker_Pics/Alan-M-Golden.jpg)
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
![](/static/images/default-webinar-info.jpg)
Work Well Remotely: Healthy Habits at Home
![](https://247compliance.com/static/images/excel-data.jpg)
3-Hour Excel Automation Boot Camp: Top Ten Excel Functions …
![](https://247compliance.com/static/images/73.jpg)
Project Management for administrative professionals
![](/static/images/default-webinar-info.jpg)
4-Hour Virtual Seminar on Transformational Leadership - The…
![](https://247compliance.com/Speaker_Pics/csd.jpg)
IRS Form 1099 Reporting: Compliance Requirements
![](/static/images/default-webinar-info.jpg)
Understanding Emerging Payments Fraud and Risk Management
![](https://247compliance.com/Speaker_Pics/laboratory-3827743_960_720.jpg)
![](/static/images/default-webinar-info.jpg)
Navigating FDA Inspections: From SOP to 483
![](https://247compliance.com/static/images/fatal-errors.jpg)
Implementing an Effective Human Error Reduction Program
![](/static/images/default-webinar-info.jpg)
![](/static/images/default-webinar-info.jpg)
Fair Debt Collection Practices Act (FDCPA)
![](https://247compliance.com/static/images/pharma-trend.jpg)
Sunshine Act Reporting - Clarification for Clinical Research
![](https://247compliance.com/Speaker_Pics/student-849821__340.jpg)
![](/static/images/default-webinar-info.jpg)
SOPs - How to Write Them to Satisfy those Inspectors
![](/static/images/default-webinar-info.jpg)
Complying with the NEW I-9 and E-Verify Regulations - The I…
![](/static/images/default-webinar-info.jpg)
TIN Matching to Reduce Your B-Notices and Eliminate Propose…
![](https://247compliance.com/static/images/sick.jpg)
Stressed Out: How to Handle Conflict, Difficult People and …
![](https://247compliance.com/Speaker_Pics/food-2373415_960_720.jpg)
California Meal and Rest Breaks: What You Dont Know Can Cos…
![](https://247compliance.com/Speaker_Pics/office-3295556__340.jpg)
![](/static/images/default-webinar-info.jpg)
![](https://247compliance.com/Speaker_Pics/ver.jpg )
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
![](https://247compliance.com/static/images/hr-employee.jpg)
Using Behavior Based Interviewing for Finding the Best Matc…
![](https://247compliance.com/Speaker_Pics/currency-3118767_960_720.jpg)
Why EBITDA Doesn't Spell Cash Flow and What Does
![](/static/images/default-webinar-info.jpg)
Diversity, Equity and Inclusion in the Workplace - Celebrat…
![](/static/images/default-webinar-info.jpg)
![](/static/images/default-webinar-info.jpg)
Gossip-Free: Leadership Techniques to Quell Office Chatter
![](/static/images/default-webinar-info.jpg)
Form 1099 Update 2024: Latest Forms, Rules and Reporting Re…
![](/static/images/default-webinar-info.jpg)
Your Workplace Culture for 2024: If You Don't Get It Right,…
![](https://247compliance.com/static/images/fda-ai.jpg)
FDA Regulation of Artificial Intelligence/ Machine Learning
![](https://247compliance.com/static/images/peer-to-boss.jpg)
![](https://247compliance.com/static/images/emotional-intelligence.jpg)
Emotional Intelligence: Mastering the Emotions of Great Lea…
![](https://247compliance.com/static/images/travel-expenses.webp)
Dealing With Difficult People In Life & Work
![](/static/images/default-webinar-info.jpg)
Onboarding is Not Orientation: How to Improve Your New Hire…
![](/static/images/default-webinar-info.jpg)
Employee or Independent Contractor – U.S DOL Announces 2024…
![](https://247compliance.com/Speaker_Pics/qalification.jpg)
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
![](/static/images/default-webinar-info.jpg)
I-9 Audits: Strengthening Your Immigration Compliance Strat…
![](/static/images/default-webinar-info.jpg)
Re-imagine Finance & Accounting Made Simple. Three Webinars…
![](/static/images/default-webinar-info.jpg)
Leadership: Strategic Planning and Decision Making
![](/static/images/default-webinar-info.jpg)
Tattoos, hijabs, piercings, and pink hair: The challenges …
![](/static/images/default-webinar-info.jpg)
Understanding the incredible uses and fallbacks of ChatGPT