I am impressed with the labeling team at Network Partners. We have been working through the EU MDR gaps on labeling and the team has been hitting it out of the park. Network Partners is closing our gaps and making my internal Packaging Engineering Department look good.
Your Compliance is Our Priority
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.
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)
Post Market Surveillance (PMS)
eIFUs, PILs, Labeling Revisions, and Patient Implant Cards
Increased considerations for Clinical Evaluation Reports
May 26, 2021
Updated Date of Application (DOA) — MDR Compliance Required for Class I Devices and PMS Requirements in Effect
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.
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.
We provide gap assessments on technical documents and clinical evaluation reports to put in place and execute a plan for remediation.
EU MDR compliance cannot exist without a gap analysis and remediation plan. Network Partners is well versed in planning for execution.
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.
What Our Clients Say
We have the labeling, packaging, regulatory and project management resources you need for EU MDR.
Packaging Engineering ManagerMedical device client - New Jersey
I have placed about a dozen contracts with Network Partners across several business units and each placement has been extremely positive. The NP talent is highly skilled, motivated and able to work independently. They have proven to be highly valuable contributors in both staff augmentation roles and full project ownership roles. NP is my choice for flexing my staff to meet my expanding workload!Senior Director, PackagingMedical Device Client - Global
It’s been a pleasure working with Network Partners. The team is highly responsive and able to explain details around printer validations. The team is easy to work with, which helps me manage other high priority projects. They’ve exceeded my expectations in a great way.Senior Manager, Packaging & LabelingMedical Device Client - California
When I consider the use of contract resources, it is because we have work that needs attention immediately. What I want in a contract resource provider is the ability to call for support and feel confident my needs would be met with simplicity, speed and high quality execution. When I call Network Partners for support, I get what I want and when I need it.Senior Director - PackagingMedical Device Client - Global
EU MDR Resources
The IVDR Top 8 – A Roadmap For Transitioning To The European in vitro Diagnostic Medical Devices Regulation (IVDR)
The Time for Action is Now. Get Your Roadmap for IVDR Compliance. Notified Body (NB) representatives have been quoted calling EU IVDR the “big bomb” and are advising IVD industry that if they haven’t started already, they may already be too late to meet the deadline for EU IVDR implementation on May 26, 2022. No […]
What You Need To Know About EUMDR Article 117
— Article 117 of the new EU MDR Although short, Article 117 has significant impact to the manufacturers of integral drug-device combination products (for example pre-filled syringes, pre-filled injector pens or novel pre-filled devices) and device manufacturers that supply their products to be sold with pharmaceutical or biopharmaceutical products (for example an empty syringe). Do […]
What You Need To Know About eIFUs, Implant Cards & the EU MDR
eIFUs, Implant Cards and the EU MDR The EU MDR’s impact on eIFUs and implant cards has changed the approach of how to meet new requirements as well as provide the necessary information. Does your team need help closing the gaps for EU MDR compliance? Contact Network Partners, we can help you navigate the new […]