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 this free, exclusive webinar event, Greenlight Guru founder Jon Speer will moderate a panel of industry experts in a lively discussion about audits and inspections.
A free, in-depth webinar on how manufacturers can evaluate whether biocompatibility testing and risk mitigations are necessary when making changes to a medical device.
A free, in-depth webinar explaining how to integrate cybersecurity into existing medical device development processes, resulting in secure products and needed artifacts for regulatory submission and sales, with minimum burden on budgets and schedules.
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."