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This eBook of the Ultimate Guide to Postmarket Surveillance covers the regulations that manufacturers must follow, along with best practices and tips for carrying out PMS ...
Access this free guide on how to plan a clinical data management setup for EDC Systems.
A free guide supplying medical device manufacturers with 7 best practices for how to design an electronic case report form.
In-depth guide on the process of sample size calculation for medical device studies.
In-depth guide on medical device classification and requirements under EU MDR.
Good supplier management is critical to marketing a medical device. This comprehensive guide covers everything you need to know about suppliers and purchasing controls.
A comprehensive guide to UDI (Unique Device Identification) for medical device manufacturers.
A comprehensive guide to software as a medical device (SaMD) packed with insights into how these products are regulated and what manufacturers should expect when building one.
Ultimate guide supplying medical device manufacturers with an overview of both generic and specific PMCF activities, and guidance on when and how to include them in your PMCF plan.
A four-part comprehensive guide to help manufacturers understand the essentials of clinical evaluation for medical devices in the European Union (EU).
A comprehensive list of most frequently asked questions and their answers about ISO 15223-1:2021 Fourth Edition, the latest version of the international standard for the ...
A white paper to guide users in the medical device industry through every stage of the product development process, from evaluating manufacturing methods and 3D printing ...
A valuable resource to help medical device manufacturers bridge the connection between design control and risk management processes in order to design, develop, manufacture, ...
In this report, we wanted to provide you with a holistic ...
Understand what today’s medical device professionals are doing or using to accelerate product development, ensure compliance, and promote quality based on original research ...
Comprehensive guide to help medical device companies learn about training management, including compliance requirements and proven ways to promote total competence of the ...
In-depth guide covering the requirements of 21 CFR Part 820, FDA's quality system regulation for medical devices, including tips on how to comply and avoid common ...
In-depth guide for medical device companies on how to control documents and improve procedures, with actionable solutions to common problems with document control activities ...
Learn the most up to date recommendations and best practices from the ISO 14971:2019 standard and how you can start to use risk management as a tool - not a checkbox ...
The best QMS software comparison guide for medical device companies that will help you choose a quality management system solution that strategically benefits your product and ...
Know what questions to ask software vendors that give your medical device company the necessary information to consider when selecting a QMS software solution.
A definitive guide on change management best practices to help medical device companies understand and manage changes to documents, products, processes and more.
A guide to the top 5 recommended best practices that medical device companies should consider when choosing a quality management system (QMS) solution.
A complete guide for medical device manufacturers looking for guidance on how to plan for a successful product launch and maintain regulatory compliance across global ...
In-depth overview of Agile design and development processes to improve risk and quality management of medical devices that fulfill user and business needs.
This is the essential guide to help you prepare your Quality Management System (QMS) for the new EU MDR before the transition period ends on May 26, 2020.
ISO 13485 - Ultimate Guide to the Quality Management System (QMS) for Medical Devices offers industry professionals everything related to the topic. Greenlight Guru eQMS ...
This eBook provides 15 reasons you need a solution such as Greenlight Guru that provides built-in compliance, provides traceability, takes little time to implement, and is ...
We'll take you through each section of 21 CFR Part 11, FDA's regulation for electronic documentation and electronic signatures. We'll explain what the ...
Learn how to manage all the changes to your medical device QMS to comply with the new regulations & standards; EU MDR, EU IVDR & ISO 13485:2016.
Paper-based quality management systems are no longer an option. The right quality management software platform can save time, money, and allow you to focus on quality.
Looking to submit your FDA 510k? This step by step guide provides step-by-step instructions on preparing an FDA 510(k) submission to gain market clearance.
The art of defining design inputs & design outputs for FDA compliance by medical device manufacturers.
How to start using FDA design controls to your benefit today & implement a process to actual improve your medical device product development efforts.
Learn how to implement and maintain a risk-based CAPA process while avoiding the most common pitfalls at your medical device company.
Everything device makers need to know about the Risk Management + Design Controls connection in medical device product development.
If you find yourself in this situation, learn how to respond to FDA 483's & warning lettering (includes a free response template)
Here are 15 items medical device startups need to address early on as a best practice to ensuring FDA / ISO regulatory compliance.
Greenlight Guru presents a step-by-step guide for determining how your medical device will be classified by U.S. FDA, European Commission, and Health Canada.