Streamline your transition to compliance
EU MDR CONSULTING
OUR EU MDR SERVICES
Impact Assessment
- Medical device classification review
- Analyze product documentation current-state vs future-state
Design Dossier & Tech Document Gap Assessment
- Outline specific documentation changes between EU MDD and EU MDR regulations for your products
Gap Assessment of Key Chemical/Material Restrictions (Such as those found in REACH, RoHS, BPR, & CLP)
- Carcinogens
- Mutagens
- Reproductive Toxins
- Endocrine Disruptors
Quality System Gap Assessment
Mock EU MDR Audit
Gap Response Plan
Notified Body Submission/Response
Post-Market Surveillance of Medical Devices
- Vigilance reporting
- Trend reporting
- EUDAMED database updates
Clinical Evaluation Reports (CER)
- MedDev 2.7.1 Rev. 4
- MDR Updating
Training
- On-site EU MDR training and overview
- Requirements
- Timelines
- Customer/class-specific requirements
- Clinical evidence strategies
- Implementation of best practice
How can we help?
OUR MDR SERVICES
Impact Assessment
- Medical device classification review
- Analyze product documentation current-state vs future-state
Design Dossier & Tech Document Gap Assessment
- Outline specific documentation changes between EU MDD and EU MDR regulations for your products
Gap Assessment of Key Chemical/Material Restrictions (Such as those found in REACH, RoHS, BPR, & CLP)
- Carcinogens
- Mutagens
- Reproductive Toxins
- Endocrine Disruptors
Quality System Gap Assessment
Mock EU MDR Audit
Gap Response Plan
Notified Body Submission/Response
Post-Market Surveillance of Medical Devices
- Vigilance reporting
- Trend reporting
- EUDAMED database updates
Clinical Evaluation Reports (CER)
- MedDev 2.7.1 Rev. 4
- MDR Updating
Training
- On-site EU MDR training and overview
- Requirements
- Timelines
- Customer/class-specific requirements
- Clinical evidence strategies
- Implementation of best practice
Ensure Your Transition Is Efficient & Successful
On May 26, 2021, the EU Medical Device Regulation (EU MDR) took effect, replacing the 1993 Medical Device Directive (MDD). The new standards aim to improve patient safety and adverse event reporting, while also extending time to market and mandating changes to quality management systems, clinical trials, post-market surveillance, and more. With our years of experience and regulatory expertise, Fang Consulting can guide your transition to EU MDR compliance, whether it involves a complete system overhaul, technical file review, or mock audit support. We also offer independent quality control checks to prevent gaps that could impede certification, and can assist in responding to non-conformities from notified bodies.
