End-to-End Medical Device Regulatory Compliance Solutions
From first submission to post-market surveillance, we handle the paperwork so you can focus on changing healthcare.
Regulatory Strategy & Gap Analysis
We help medical device manufacturers navigate complex global regulations by developing a customized compliance roadmap tailored to your product and target markets. Our experts conduct a thorough gap analysis of your existing documentation and processes, identifying missing requirements under FDA, EU MDR, or other regional frameworks, then provide actionable steps to address deficiencies—saving you time, reducing costly delays, and ensuring a smoother path to approval. With a clear strategy in place, you can avoid surprises, optimize resources, and accelerate market entry with confidence.
Comprehensive Regulatory Roadmapping
- Target market analysis (US, EU, APAC, MENA)
- Predicate device identification for 510(k)
- Classification confirmation per FDA/EU MDR/other regions
Gap Assessment & Remediation
- Technical documentation audits
- Compliance benchmarking against ISO 13485, EU MDR, FDA 21 CFR
- Risk mitigation strategies
Our Process
510(k) Submissions & FDA Compliance
Navigating FDA regulations is critical for bringing your medical device to market, and our 510(k) submission service ensures a smooth, efficient approval process. We provide end-to-end support—from predicate device selection and submission strategy to document preparation and FDA communications—helping you demonstrate substantial equivalence and achieve faster clearance. With a 92% first-pass success rate, we minimize delays, reduce costs, and guide you through De Novo classifications, PMA pathways, and post-submission follow-ups, ensuring full compliance with 21 CFR Part 820 and other FDA requirements. Let us handle the complexities while you focus on innovation.
Submission Type Guidance
- Traditional / Abbreviated / Special 510(k)
- De Novo classification petitions
Full Submission Package Development
- Substantial equivalence demonstrations
- Biocompatibility/sterility testing coordination
- FDA eCopy preparation
FDA Negotiation Support
- Pre-submission meeting packages
- Interactive review response management
Success Metrics
- 92% first-pass approval rate
Included Deliverables
- FDA correspondence templates
- Predicate comparison matrices
- Ongoing change impact assessments
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.
USA Market Access
Our FDA regulatory experts provide complete support for all medical device approval pathways including 510(k), PMA, and De Novo submissions. We ensure full compliance with 21 CFR regulations while optimizing your regulatory strategy to accelerate approvals in the world’s most important medical device market. From pre-submission meetings and FDA communications to post-market surveillance requirements, we guide you through every step of the U.S. regulatory process. Our team includes former FDA reviewers who understand exactly what the agency looks for in successful submissions, giving you a competitive advantage in achieving timely clearances.
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.
Quality Management System
We design, implement, and optimize ISO 13485-compliant Quality Management Systems tailored to your medical device business, ensuring you meet FDA 21 CFR Part 820, EU MDR, and other global regulatory requirements. Our end-to-end QMS solutions include document control, process mapping, internal audit programs, and staff training to create an audit-ready system that not only achieves certification but drives operational excellence, reduces compliance risks, and scales with your growth – turning quality compliance into competitive advantage.
| Service Component | Description |
|---|---|
| Document Control Systems | Comprehensive systems to manage policies, procedures, and records in compliance with regulatory requirements. Ensures version control, traceability, and easy retrieval during audits. |
| SOP Development | Creation of standardized operating procedures tailored to FDA and EU MDR regulations, ensuring alignment with quality and safety standards. |
| Electronic QMS Integration | Implementation of cloud-based QMS platforms to streamline documentation, workflows, and compliance tracking for efficiency and real-time access. |
| Audit Readiness | Proactive preparation to ensure seamless regulatory inspections and minimize compliance risks. |
| Mock FDA/Notified Body Audits | Simulated audits to identify gaps, test staff preparedness, and refine responses before official inspections. |
| CAPA Management Systems | Tools and processes to systematically address non-conformities, investigate root causes, and implement corrective/preventive actions. |
| Staff Training | Customized programs to empower teams with regulatory knowledge and practical skills. |
| GMP Training Programs | Interactive training on Good Manufacturing Practices (GMP) to ensure adherence to quality standards in daily operations. |
| MDR/FDA Webinar Library | On-demand access to expert-led sessions on evolving regulations (EU MDR, FDA updates) for continuous learning. |
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