How to Use Design Controls and Risk Management to Reduce Complaints and CAPAs

Medical Device, Medical Device Safety and Regulation, Medical Device Design,
  • Tuesday, September 07, 2021

We all know how much emphasis FDA inspectors and ISO auditors place on complaint and corrective and preventative action (CAPA) processes. In fact, year after year, the CAPA process is consistently ranked as the #1 or #2 reason medical device companies are cited for 483s and warning letters.

What if there were things that could be done to minimize the struggles and challenges associated with quality events, like complaints and CAPAs?

Good news: the number of customer complaints and the volume of CAPA investigations can be reduced through good product development, design controls and risk management practices.

Register for this free webinar to hear 22-year medical device industry veteran and founder of Greenlight Guru, Jon Speer, share some of the most common challenges manufacturers experience with managing customer complaints and CAPAs. Participants will learn actionable tips and best practices for optimizing design controls and risk management processes and ways to leverage these practices to improve the overall health of quality management systems (QMS).


Jon Speer, Greenlight Guru

Jon Speer, Founder & VP QA/RA, Greenlight Guru

Jon is the founder and VP of QA/RA at Greenlight Guru (quality management software exclusively for medical device companies) and a medical device guru with nearly 20 years industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That’s why he created Greenlight Guru to help companies move beyond compliance to True Quality.

Message Presenter

Who Should Attend?

  • Quality Assurance and Quality Control
  • Regulatory Affairs and Compliance
  • Manufacturing
  • Supplier Management
  • Internal, External and Quality Auditors
  • Document Control
  • Production
  • Operations
  • Suppliers to the Medical Device Industry
  • R&D and Product Development

What You Will Learn

In this webinar, participants will learn:

  • The influence that design controls have on customer complaints
  • How customer complaints impact your CAPA system
  • Best practices for design controls
  • Best practices for risk management
  • Risk-based approaches to managing customer complaints and CAPAs

Xtalks Partner

Greenlight Guru

Greenlight Guru is the only all-in-one medical device success platform helping solve the unique challenges of device makers across their entire product’s lifecycle. The platform helps companies bring safer products to market faster, simplifies FDA and ISO regulatory compliance, and provides a single source of truth by connecting the management of quality, product development, and regulatory processes. Greenlight Guru’s platform is used by over 500 medical device companies across the globe to push beyond baseline compliance and achieve True Quality for their devices. For more information, visit

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