Thanks, Dave. I invite readers of this article to visit https://medgroup.biz/10x since design controls will be a topic we cover at April's 10x Medical Device Conference in New Jersey.

Good advice. Another pitfall that stems from having the "Design Controls are just documentation" mindset is delegating the Design Control effort to a member of the engineering team for the wrong reasons; reasons like who is least over-loaded, who objects the least etc. You wouldn't choose the same rationale to allocate resources to SW or ME design. For Design Controls to be effective, they must be implemented by someone who understands their value, and who is motivated.

Great article summarizing well those best practices

For Design Controls to be effective, they must be implemented by someone who understands their value, and who is motivated.

Julie Omohundro I would expect the product manager, not a member of the engineering team, to be responsible for design controls. Only two design controls (verification and output) are engineering activities.

Great article, thank you for posting. I think that all design controls mentioned are engineering activities. User needs and Design inputs are the domain of the Systems Engineer and are critical to set a solid foundation for project success. Very much an engineering activity.

"Design Controls" are a burdensome task - administrative minutia. Recast the perspective to "design control" - which is which is critical to quality, critical to developing design constraints, critical to developing a product history, critical to efficient design transfer. Most good development teams are already doing the work - just need a simple framework / understanding to help with the documentation.

David Merriman is correct . . . most create burdensome approaches to managing and maintaining design controls. It doesn't have to be this way, however.

Happy to share an alternative that keeps you compliant and allows you to stay focused on design and development.

Julie Omohundro Tom, what is the domain of whom is a management decision that varies from company to company. Product managers are responsible for the entire product , which is comprised of the technology plus intended use. Engineers are experts in the technology. Users are the market, not the technology. Marketing, not engineering are the user experts. Design inputs are transferred from the product development team to design engineering to direct design, just as design outputs are transferred to manufacturing to direct manufacturing.

I agree with the sentiment that if you're implementing design controls processes strictly for compliance then you will end up with something burdensome and unwieldy. In my experience, if the quality department are the managers of the process, rather than engineers, then thisis exactly what you end up with. In a great system, design controls should follow best engineering practices and should fit in as an easy addition to other development work.

Good article. But reality is that still system is developed and based on that documentation is released. This delays overall product release time as design control find flaws in design very late. Ideal scenario's are rare one....🤔