Medical Device & Diagnostics Regulatory Services
Expert guidance from concept to market - FDA 510(k), CE Mark, CDSCO approvals
Comprehensive Regulatory Support
From strategy development to post-market compliance
Quality Assurance & Compliance
- ISO 13485 QMS Implementation
- Risk Management per ISO 14971
- Gap Analysis & DHF Remediation
- Post-Market Quality Support
- Verification & Validation
- Manufacturing Process Development
- Supplier & Internal Audits
- SOPs & Documentation
Regulatory Affairs
- Regulatory Strategy & Planning
- 510(k) Preparation & Submission
- Technical File Creation (MDR/IVDR)
- Labelling & UDI Implementation
- Predicate Device Selection
- Pre-Submission Meetings (FDA)
- Notified Body Liaison
- CDSCO Registration Support
Clinical Evaluation Report (CER)
- Clinical Evaluation Plan (CEP)
- Literature Search & Review
- Clinical Background Analysis
- State of the Art Assessment
- PMS Data Integration
- Risk Management Integration
- Benefit-Risk Analysis
- Notified Body Approval Support
Performance Evaluation Report (PER)
- Performance Evaluation Plan (PEP)
- Scientific Validity Report (SVR)
- Analytical Performance Report (APR)
- Clinical Performance Report (CPR)
- Tech File Submission & Review
- IVDR Readiness Audits
- Gap Assessment in PER
- Mock Audits
Post-Market Surveillance
- Complaint Handling & Investigation
- Adverse Event Reporting
- Field Safety Corrective Actions
- CAPA Implementation
- PMS Protocols & Reports
- Post-Market Performance Follow-up
- Post-Market Clinical Follow-up
- Trend Analysis & Reporting
Regulatory Affairs Consulting
- Global Regulatory Assessment
- 510(k), PMA, De Novo Pathways
- Medical Device Reporting (MDR)
- Labelling & IFU Development
- Audit Remediation Support
- MDD to MDR Transition
- Device Classification (EU MDR)
- GSPR Compliance
Regulatory Pathways
Navigate complex regulatory landscapes with confidence
🇺🇸 FDA (United States)
- ✓ 510(k) Pre-Market Notification
- ✓ De Novo Classification
- ✓ Pre-Market Approval (PMA)
- ✓ QMS per 21 CFR Part 820
🇪🇺 CE Mark (European Union)
- ✓ MDR 2017/745 Compliance
- ✓ IVDR 2017/746 Compliance
- ✓ Technical Documentation
- ✓ Notified Body Assessment
- ✓ UDI Database Registration
🇮🇳 CDSCO (India)
- ✓ Medical Device Registration
- ✓ Import License
- ✓ Form 41 / Form 44
- ✓ Manufacturing License
Key Deliverables
Comprehensive documentation for regulatory success
Design History File (DHF)
Technical Documentation
Risk Management File
Clinical Evaluation Report
Biocompatibility Assessment
Labeling & IFU
QMS Documentation
Submission Dossiers
Device Classifications We Support
FDA: Class I, II, III
IVDR: Class A, B, C, D
CDSCO: All risk categories
Success Story Highlight
Rapid FDA 510(k) Clearance for Cardiac Monitor
Client: CardioTech Solutions (US-based startup)
Challenge: Complex predicate selection, incomplete DHF, tight investor timeline
Results:
- FDA 510(k) clearance in 6 months (50% faster than average)
- Zero major deficiencies
- Client secured $5M Series A funding post-approval
- 98% complete documentation on first submission
Start Your Device Approval Journey
Schedule a free regulatory assessment with our medical device experts
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