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.
A free, in-depth webinar covering the inside scoop from off-the-record interviews held with both manufacturers and notified bodies to identify areas of misalignment and challenges they are facing during this transition period.
A free, in-depth webinar covering the benefits and risks associated with FDA Breakthrough Designation and what it means for reimbursement, FDA interactions and time to market.
A free, in-depth webinar covering the “new” safety and performance based 510k (sp510k).
A free, in-depth webinar covering various additive manufacturing methods and 3D printing technologies companies can use for making medical devices, validating workflows, and executing regulatory strategies.
Co-founder & CEO, Centese
President, CEO, Koios Medical,
CFO, Koios Medical,
Director of Regulatory Compliance and Quality, Koios Medical
Principal/Co-founder, Two Harbors Consulting
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“Partnering with Greenlight Guru provides you with a team that’s on your side, who are all medical device industry pros and understand what companies like ours go through.”
"Greenlight Guru provides an Electronic Quality Management System (eQMS) for medical device companies to ensure quality standards are met without requiring that the end user be a ‘quality guru’."
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