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
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.
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