Our Services

You have the road map, we have the playbook. Are you resourced for success?

Experienced Fixed-Term Life Sciences Professionals, From Day 1

Execute Your EU MDR Plan Seamlessly

EU MDR drastically increased the complexity of requirements the medical device industry now faces…and your day-to-day. Network Partners’ professionals identify gaps, develop remediation plans and get you the support you deserve. Get seamless integration and total compliance in your EU MDR program now.

Key Changes

MDD v. EU MDR

New EU Medical Device Regulation (EU MDR) differs from the
current Medical Device Directive (MDD) in these key areas:

Changes in Safety and Performance Requirements (GSPRs vs ERs)

     

Technical Documentation

     

Post Market Surveillance (PMS)

     

ISO 11607:2019

     

eIFUs, PILs, Labeling Revisions, and Patient Implant Cards

     

Increased considerations for Clinical Evaluation Reports

     

Important Dates

May 26, 2021

Updated Date of Application (DOA) — MDR Compliance Required for Class I Devices and PMS Requirements in Effect

4-9 Months

Standard Timeline to Total Compliance Complete with Gap Assessments, CER Updates, Verification and Validation

Get Equipped for Success

Navigating the New Regulations Without the Burden

Our team of Subject Matter Experts executes our proprietary playbook to efficiently bring your medical devices into compliance with EU MDR.

Program Management

Whether you are starting from scratch, have a plan, or are stalled, Network Partners is your one-stop-solution for EU MDR Program Management and compliance.

Regulatory Compliance

We provide gap assessments on technical documents and clinical evaluation reports to put in place and execute a plan for remediation.

Packaging Compliance

EU MDR compliance cannot exist without a gap analysis and remediation plan. Network Partners is well versed in planning for execution.

Labeling Compliance

Take the stress of EU MDR off your plate and focus on your product. Network Partners can leverage its team to do the heavy lifting.

Still have EU MDR questions?
Get expert support from Network Partners.

This is where the HubSpot form will render.