Our document provides a gap analysis of the manufacturer requirements described in EU MDR 2017/745. For each article applicable to manufacturers, you'll find concrete methods for direct implementation
Discover methods derived from our various experiences in surveillance and EU MDR 2017/745 certification audits.
Don't overlook any regulatory requirements anymore.
✅Quickly identify all manufacturer requirements in the MDR 2017/745.
✅Ensure you don't miss any MDR 2017/745 articles applicable to manufacturers.
✅Obtain compliant methods to implement for each article.
Whether you're a beginner, regulatory affairs expert, consultant, or a regulatory affairs team, this gap analysis will be valuable for implementing manufacturer regulatory requirements and accessible at any time
"We have "checklists", but adding those frequent updates to each specific product type is key. This compliancy list for MDR 2017/745 is worth a peek"
Project Management, Medical Device Compliance, R&D
"We purchased this gap analysis before our MDR audit, and it helped us address the final details to be fully prepared!"
QARA Manager, Co-founder
"We're a US-based startup looking to break into the European market, and this gap analysis has helped us save precious time in this lengthy process. Thanks!"
Regulatory affairs director