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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
April 18, 2024

Mastering the Design Transfer Process

In medical device development, the journey from design to manufacturing is crucial.

One of the most important (and often most challenging) phases of this journey is the transfer from design to manufacturing.

The success of your medical device in the marketplace hinges on how well you manage this design transfer. Early integration of manufacturing considerations into the design phase is essential to ensure your product meets both design specifications and production needs. 

Register for this webinar where Kyle Rose, CEO of RookQS, presents best practices to ensure your design transfer process is successful and documented properly. You'll receive detailed instructions and strategies to help you navigate the design transfer phase, enhancing production efficiency, reducing rework, and speeding up time-to-market.

Specifically, this webinar will cover:
  • How to prepare for design transfer
  • Steps to take during product development
  • Documentation responsibilities during design transfer
  • Design transfer for SaMD and SiMD
  • Best practices for managing suppliers
  • Supplier audits and design transfer
  • Equipment validation and qualification requirements 
  • Internal manufacturing tips for new companies
  • Completing design transfer process

Watch the webinar
Mastering the Design Transfer Process
Who should attend?
  • Product Development Engineers and Management
  • R&D Engineers and Management
  • Medical Device Executives
  • Quality Professionals and Management
  • Regulatory Affairs Professionals & Management
Register Now  

Hosted by

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Moderator:
Etienne Nichols

Medical Device Guru,
Greenlight Guru
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Presenter:
Kyle Rose

President,
Rook Quality Systems

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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 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.

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