Part 2 of Get Your Medical Device to Market in 10 Easy Steps: Design and Development

On today’s episode, Stacey Bruzzese welcomes Roberta Good, the founder of Goode Compliance for the second part of our 3-part series.  Stacey and Roberta dive into the design and development of medical devices.

Stacey and Roberta cover a variety of topics:

What are the tasks that make up the design and development phase?
Do people develop prototypes and when is the right time to do that?
How is human factors design applied to engineering medical device?
What records and documents need to be considered during the design and development?
How do Design for Manufacturing and Six Sigma get incorporated?
Roberta highlights the typical challenges when planning for packaging, labeling and product delivery
What’s the difference between validation and verification?
How does managing compliance through the risk management cycle help ensure quality and safety are built into the product?
How do labeling requirements affect the expiration date?

The following links have useful companion information for this episode:

FDA Labeling (General)

https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling

UDI System:

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system

Investigational Device Exceptions:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812

Test method validation article on IVT Network:

http://www.ivtnetwork.com/article/test-method-validation-medical-devices

http://www.ivtnetwork.com/article/method-validation-medical-devices-regulatory-guidance

Method Validation Guidelines:

https://www.fda.gov/science-research/field-science-and-laboratories/method-validation-guidelines

Design Controls:

https://ubm.box.com/s/gwkqg1wweccrjs683bjp28x8zsu7qnhc

 

Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers.  After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge.  In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.   

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.