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.
Free, in-depth webinar covering the human factors engineering process and how to comply with the applicable regulatory requirements of the US, UK, EU, and other international standards.
A free, in-depth webinar covering BDD and STeP application processes and why getting these designations early in the regulatory process can help clear a device’s pathway to approval.
Free, in-depth webinar presented by Doug Browne, Director of Mechanical Engineering and Design Transfer at Sunrise Labs, and Ted Trask, Director of Corporate QA/RA at Cirtronics, who share tips from their decades of experience transferring new product designs for medical products into manufacturing.
A free, in-depth webinar covering the best practices for setting up an agile QMS which can be adapted and optimized concurrently with software as a medical device (SaMD) development phases.
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
"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’."
"If I were to quantify it, it's days of time saved. The cost of Greenlight Guru is repaid in efficiency."
"Greenlight Guru was the only way we could get our small team to move really quickly with a QMS."
"Showing traceability and documenting takes seconds in Greenlight Guru, compared to hours in a paper-based system."
By Jon Speer
Medical Product Outsourcing July 6th, 2021
By Brandon Henning
Medical Product Outsourcing July 1st, 2021
By Jon Speer
Quality Digest, June 2, 2021