How to Get Your 510(k) Approved on Your First Try (And Why Only 31% Succeed)

Life Sciences, Clinical Trials, Medical Device, Medical Device Design,
  • Wednesday, October 06, 2021 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

Did you know that between January and June of 2015, 69% of 510(k) applications were rejected their first time? Even though there have been significant changes to the content required in a 510(k) submission since the agency released their guidance in 2005, this should not be the case. So, what can be done to better manage a team’s 510(k) expectations? How can a submission be constructed in a way that’s least likely to be rejected?

Register for this webinar to hear about the common pitfalls that plague first-time medical device founders when submitting their device to the FDA and share the secrets of industry veterans who have mastered the art of regulatory clearance.

Speaker

http://Jon%20Speer,%20Greenlight%20Guru

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?

  • Medical Device Industry Executives
  • Quality Professionals and Management
  • Regulatory Professionals and Management
  • Clinical Affairs Professionals and Management
  • R&D Engineers and Management

What You Will Learn

In this webinar, participants will learn:

  • The components and process of submitting your 510(k)
  • The typical timeline for 510(k) submissions
  • Key requirements for 510(k) submissions
  • Common pitfalls that occur and how to avoid them
  • The tips and tricks that we’ve learned from helping hundreds of medical device companies get 510(k) clearance

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 http://www.greenlight.guru.

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