November 30, 2023

Mastering Medical Device Audits: A Proven Formula

A medical device audit, whether routine or unannounced, can bring waves of complexities and stresses for even the most experienced manufacturer.

So, how can you plan for a successful audit, while reducing the complex and stressful nature of this important regulatory event?

Join us for an informative webinar led by Kyle Rose, President of RookQS, as he delves into proven best practices from his worldwide team of consultants who have helped all types of medical device companies prepare for ISO audits and FDA inspections and achieve optimal results without the headaches. 

This free webinar will give you the tools and knowledge you need to master your next medical device audit, including specific areas to focus on during the audit preparation, how to interact with the auditor, roles within the company and their responsibilities during the audit, and how to respond to any audit findings.

Watch the webinar

Mastering Medical Device Audits A Proven Formula

Specifically, this webinar will cover:
  • First things to do when you receive an audit notice
  • Templates for a pre-audit review and preparation 
  • Documents to prioritize if there are gaps
  • Roles and responsibilities of the company employees during the audit
  • How to interact with the auditor
  • Closing the audit 
  • Completing your audit response/CAPAs for any audit findings 
Who should attend?
  • Regulatory Affairs Professionals & Management
  • Quality Professionals and Management
  • Medical Device Executives
  • Product Development Engineers and Management
  • R&D Engineers and Management
Register Now  

Hosted by

Etienne Nichols

Medical Device Guru,
Greenlight Guru

Kyle Rose headshot-round
Kyle Rose

Rook Quality Systems

Greenlight Guru logo

About Greenlight Guru

Greenlight Guru is the leading connected, cloud-based platform purpose-built for MedTech companies. The end-to-end solution streamlines product development, quality management, and clinical data management by integrating cross-functional teams, processes, and data throughout the entire product lifecycle. Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster and with less risk.

Visit our homepage to learn more.


About Rook Quality Systems

Rook Quality Systems is a consulting firm dedicated to helping early-stage medical device companies develop and maintain effective and efficient quality systems.

Rook provides clients with all of the right resources and necessary tools to comply with regulations in domestic and international markets. Rook's team provides expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. We work with a wide range of devices (including class I-III devices, SaMD, and IVDs).

Visit their website to learn more.

Featured In