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 application of medical device symbols on labels.
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 technologies to specific regulatory requirements, for commercializing and marketing end-use 3D printed medical devices.
A valuable resource to help medical device manufacturers bridge the connection between design control and risk management processes in order to design, develop, manufacture, and sell the most safe and effective devices.
In this report, we wanted to provide you with a holistic picture of what other medical device teams are doing to prepare for the upcoming EU MDR deadline and give you a full 60 day action plan to get prepared, regardless of your current state of preparedness.
Understand what today’s medical device professionals are doing or using to accelerate product development, ensure compliance, and promote quality based on original research findings from hundreds of medical device professionals.
Comprehensive guide to help medical device companies learn about training management, including compliance requirements and proven ways to promote total competence of the members of a medical device organization.
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 pitfalls.
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 and methods for implementing a document management system that enables product and business success.
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 activity.
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 company.
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 markets.
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 platform automates regulatory compliance with ISO 13485:2016, FDA, ISO 14971, so companies can focus on true quality of devices.
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 augmented by experts with more than a decade in the medical device industry.
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 requirements actually mean and expound the most important points for you to know as a medical device company.
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)
A step by step guide to complying with ISO 13485 and FDA quality management system requirements for medical device companies.
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.
Learn exactly what design verification and design validation are, how they are the same, how they are different, and best practices for medical devices.
