MDR Transition and Tech File Changes: What Medical Device Companies Need to Know

Recent changes to European regulations have sparked a lot of interest and intrigue, and even more questions, such as "Why did the change occur?" and "What are the distinct differences between MDD and MDR"?

So, what specifically do medical device companies need to know about these MDR and Tech File changes?

To bring simplicity to complexity, Rook Quality Systems Sr. Quality Manager Chandler Thames will expand on the new MDR requirements, and provide key insights and guidance for all of those interested in this timely topic during this free, in-depth webinar. Register now!

Watch the webinar

RQS Webinar 7-14-22
Specifically, this webinar will cover:
  • What clinical evaluation requirements are needed?
  • How might risk management be impacted
  • How to prepare your Technical File for MDR
  • Who reviews the Technical File?
  • What are the minimum requirements for a Technical File?
Who should attend?
  • Regulatory Affairs Professionals & Management
  • Quality Professionals and Management
  • Medical Device Executives
  • Clinical Affairs Professionals and Management
  • Complaint and CAPA Management & Professionals
Register Now  

Hosted by

Chandler Headshot - Patrick Sherman
Presenter: Chandler Thames

Sr. Quality Manager, Rook Quality Systems

Moderator: Etienne Nichols

Medical Device Guru & Community Manager, Greenlight Guru

About Rook Quality Systems

Since 2012, Rook has been dedicated to helping medical device companies develop and maintain effective and efficient quality systems, and to providing them with the right resources and expert insight. Our mission is to enable our clients to implement compliant Quality Management Systems (QMS) to ensure that they can efficiently produce effective and reliable medical devices. We build these QMSs so that our clients can get their devices to market faster than standard methods, and once on the market, manage these systems to continue producing quality devices.

Rook specializes in Quality and Regulatory strategies for early-stage medical device clientele, providing expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. Rook works with a wide range of devices, including class I-III devices, SaMD, and IVD, collaborating with your team on a holistic approach to getting your device to market as efficiently as possible. Visit their website to learn more.


About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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