Everything Device Makers Need to Know About Design Controls

“Engineers who design and develop new devices are always telling me they hate design controls,” Greenlight Guru co-founder Jon Speer tells me.

“They say, ‘Why are you talking to me about design controls?’

Because without tight design controls, how do you prove you designed a safe and effective device that meets the indications for use?”

Jon talked intended use, user needs, design inputs, reviews, history files (DHF), and risk management; specifically,

Click to learn:

• • • The importance of getting intended use right up front
    • The difference btw user needs + verifiable design inputs
    • Which stakeholders need to be involved and why
    • How many design reviews you should hold
    • Why an FMEA alone for risk management doesn’t cut it (you need an ISO 14971 approach)

We had more than 1,300 register from all walks of engineering life:

• • Design Engineering
  • Product Development
  • Medical Device Documentation
  • QA/RA at all levels
  • Compliance Engineering
  • Quality Engineering
  • Project Management

I include a second 29-minute replay of questions and answers as well. Maybe we answered your question at the same time! 😊

---

Presenter

Moderator

About the Medical Devices Group

The Medical Devices Group is the world’s largest medical device community and the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders. Meet us at an upcoming 10x Medical Device event!

About Greenlight Guru

The greenlight guru beautifully simple Quality Management Software helps medical device companies bring devices to market faster while reducing risk and ensuring compliance. Use it to achieve end-to-end traceability, automate your quality processes, follow FDA and ISO best practices, and streamline your team communication.