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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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FREE ON-DEMAND WEBINAR
August 17, 2023

Preparing Your Technical Documentation under MDR: Proven Tips & Techniques

EU MDR continues to challenge not only industry, but the notified bodies responsible for certification.

Both the MDCG, and Team-NB have published guidance documents and position papers to provide insight into how to navigate these challenges, and the recent MDR transition delay has provided some alleviation IF you are eligible.

This has provided additional time to transition, but has not changed the requirements to demonstrate compliance under MDR.

Join Carolyn Guthrie, VP of Regulatory Affairs & Quality Assurance at Kapstone Medical, for an update on the latest news from the EU, including a review of regulation 2023/607, the relevant MDCG guidance documents, and comments from the European Association for Medical Devices of Notified bodies.

We will also go through techniques and tips to prepare your technical documentation per Annex II and Annex III, as well as ways to respond to your Notified Body.  We will also touch on the approach Notified Bodies are taking during review of technical documentation and the quality management system during the CE certification process under EU MDR 2017/745.
 

Watch the webinar
Greenlight Guru + Kapstone Medical Webinar 8-17-23
Specifically, this webinar will help you:
  • Understand the current requirements under EU MDR
  • Identify the tools made available to industry
  • Learn tips to ensure clear communication with your Notified Body
  • Understand the areas of focus for your technical documentation and QMS
Who should attend? 
  • Regulatory Affairs Professionals & Management
  • Quality Professionals and Management
  • Medical Device Executives
  • Product Development Engineers and Management
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Hosted by

Brittani Smith
Moderator:
Brittani Smith

Medical Device Guru,
Greenlight Guru
Carolyn-Guthrie-round
Presenter:
Carolyn Guthrie

VP of Regulatory Affairs & Quality Assurance,
Kapstone Medical

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About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

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.

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About Kapstone Medical

Kapstone Medical partners with physician inventors and manufacturers to develop and commercialize new medical devices. We do this by providing services for design, prototyping, patenting, quality systems, and regulatory approvals.

Kapstone Medical provides product development, quality management, and project management solutions to clients who value the knowledge, depth of experience, and resources that a highly capable outsource partner has to offer.

 
Visit their website to learn more.
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