(EU) MDR 2017/745

Navigating the EU regulatory landscape can be intricate, with numerous challenges and new requirements introduced by the EU Medical Device Regulation.

Our services are designed to provide support at any stage of the approval process.

GAP ASSESSMENTS FOR (EU) MDR & HARMONISED STANDARDS GAP ASSESSMENTS

Examine your technical file and conduct a gap analysis in comparison to the regulatory requirements. Apply the same procedure for the EU MDR harmonised standards.

TECHNICAL DOCUMENTATION SUBMISSION

Prepare the technical documentation and submission package for your device or device family for review by your notified body.

CHANGE NOTIFICATIONS

Regulatory review for device, manufacturing or quality changes and support in preparing the submission for change notification.

TECHNICAL DOCUMENTATION

Assist by either writing technical documents or by remediating existing documentation.

NOTIFIED BODY COMMUNICATION

Assistance in managing communications with notified body representatives during the lead-up to submission, throughout the review stage, and for change notifications.

SERVICES & EXPERIENCE

UK MDR 2002

OUR EXPERIENCE

QUALITY MANAGEMENT SERVICES