MDR Checklist – Is Your Company Ready?
How to prioritize your actions for EU MDR readiness ? How to succeed in a timely and a cost effective manner ?
The Checklist tool generally helps us to effectively plan our workload. But the new Medical Device Regulation (2017/745) is a mass of new requirements. And the checklist can become a nightmare or much too superficial og a tool.
This article offers a hand-on approach based on practical consulting experiences. The ultimate goal is to be regulatory compliant and at the same time, to maintain or gain competitive advantages in the moving medtech industry.
Tip 1: Take a Breath:
Tip 2: Simplify your QMS to speed your remediation projects.
Tip 3: Be aligned with the current medical product standard and increase your internal testing capabilities
Tip 4: Use operational checklists for each GSPR Flash Audit (a flash audit for each CE-marked device)
Tip 5: Build your MDR Action Plan with our proven check-list (included Free)