EU MDR & CE Marking
Navigating the complexities of EU Medical Device Regulation (MDR) compliance just became simpler. Our end-to-end CE Marking service provides expert guidance through technical documentation preparation, clinical evaluation reports, Notified Body interactions, and post-market surveillance – ensuring your medical devices meet all MDR requirements for seamless market access across Europe. With deep expertise in the new regulatory framework, we help manufacturers transition from MDD to MDR, address stringent clinical evidence demands, and maintain ongoing compliance, reducing your certification timeline by up to 40% compared to going it alone.
End-to-End Solutions
| Service Component | Key Activities |
|---|---|
| Technical Documentation | Annex II/III preparation, Clinical Evaluation Reports |
| Notified Body Liaison | NB selection, Audit preparation, Q&A resolution |
| Post-Market Compliance | PMS plans, PSURs, PMCF studies |
Critical Differentiators
- MDR Transition Specialists: Updated multiple technical files for MDR compliance
- Clinical Evaluation Experts: MDCG-compliant CERs with literature search protocols
- Unique Tool: MDR Gap Assessment Checklist
Global Market Access
We streamline international expansion by navigating the complex regulatory requirements of key markets – including the USA (FDA), Europe (EU MDR/IVDR), MENA (SFDA, GCC), and APAC (NMPA, PMDA, TGA) – ensuring your medical device meets local compliance standards efficiently. Our end-to-end support covers submission strategy, documentation preparation, local representation, and post-approval maintenance, reducing delays and costs while accelerating your path to global commercialization. Whether entering a single market or launching worldwide, we provide the expertise to turn regulatory hurdles into competitive advantages.
EU Market Access
We offer complete EU MDR/IVDR compliance services to help you efficiently obtain and maintain CE Marking for your medical devices. Our comprehensive support includes preparing all required technical documentation, conducting clinical evaluations, and managing Notified Body interactions. We specialize in helping manufacturers transition from MDD to MDR requirements, addressing critical changes in clinical evidence, post-market surveillance, and quality system requirements. With extensive experience across all device classifications, we help you navigate the complex EU regulatory landscape while ensuring ongoing compliance with evolving MDR/IVDR standards.
Post-Market Surveillance
Ensure ongoing compliance and patient safety with our comprehensive Post-Market Surveillance (PMS) solutions. We help you monitor device performance, analyze real-world data, and meet regulatory reporting requirements (such as FDA MDR, EU MDR PMCF, and ISO 14971) to proactively address risks, manage adverse events, and maintain market approval. Our systematic approach includes vigilance reporting, trend analysis, Periodic Safety Update Reports (PSURs), and post-market clinical follow-up (PMCF) studies – reducing recall risks and strengthening your product’s lifecycle management.
Our PMS Solutions
Vigilance
Reporting
- FDA Medical Device Reporting (MDR)
- EU FSCA/Field Safety Notices
- Manufacturer Incident Reports (MIR) for APAC
PMS Plan
Development
- Customized per product risk class (Class I-III)
- Integrated with your QMS
- MDCG-compliant templates
Post-Market Clinical Follow-Up
- Study design and execution
- Real-world evidence collection
- CER updates based on findings
Periodic Safety Update Reports
- Annual/biannual compilation per MDR Annex III
- Trend analysis and benefit-risk assessments
- Notified Body-ready formats
Our Differentiators
- Automated Monitoring: AI-powered signal detection from multiple sources (social media, MAUDE, EUDAMED)
- Global Coverage: Single-source solution for FDA/EU/APAC/MENA requirements
- Recall Prevention: 89% of our clients achieve zero recalls in first 3 years
Sample Deliverables
- PMS Plan Template (MDR-compliant)
- PSUR Calendar with Regulatory Deadlines
- PMCF Study Protocol Framework