Global Standards for Safer Innovations
We help organizations comply with global regulatory standards and quality management systems to ensure safe, effective, and market-ready products.
- ExpertGuidance
- GlobalCompliance
- Audit-ReadyDocumentation
- FasterMarket Access
OUR STANDARDS
Built to Meet Global Regulatory Requirements
We work with internationally recognized standards and regulations to ensure your products meet the highest levels of quality, safety, and performance.
KEY STANDARDS WE SUPPORT
European Union
EU MDR 2017/745
Regulatory Gap Assessment
- Medical Device Classification
- CE-Marking Strategy
- GSPR Checklist Preparation
- Technical Documentation Preparation
- Post-Market Surveillance (PMS)
- PMCF Documentation
7 deliverablesTalk to an expert about EU MDR 2017/745European Union
MEDDEV 2.7/1 Rev. 4 & MDCG Guidance
Clinical Evaluation & Post Marketing Surveillance (CEP)
- Clinical Evaluation & Post Marketing Surveillance(CEP)
- Clinical Literature Search
- Systematic Literature Review
- Clinical Data Appraisal
- Equivalence Assessment
- Clinical Evaluation Report (CER)
- Clinical Evidence Gap Assessment
International
ISO 14155
Clinical Investigation (CIP)
- Clinical Study Protocol Preparation
- Informed Consent Form (ICF)
- Ethics Committee Submission Support
- Clinical Monitoring
- Clinical Safety Reporting Support
- Clinical Study Report (CSR)
7 deliverablesTalk to an expert about ISO 14155International
ISO 14971
Risk Management
- Hazard Identification and Analysis
- Risk Assessment and Evaluation
- Design and Process FMEA
- Risk Control Measures
- Residual Risk Assessment
- Risk Management Report
7 deliverablesTalk to an expert about ISO 14971International
ISO 10993
Biocompatibility Studies (ISO 10993)
- Biocompatibility Studies & Biological Evaluation (BEP)
- Biological Evaluation Report (BER)
- In Vitro Cytotoxicity Testing
- Skin Sensitization and Irritation Testing
- Systemic Toxicity and Genotoxicity Assessment
- Chemical Characterization (ISO 10993-18)
- Toxicological Risk Assessment (ISO 10993-17)
7 deliverablesTalk to an expert about ISO 10993International · EU Harmonized
EN ISO 11607
Packaging Validation
- Sterile Barrier System Assessment
- Packaging Material Evaluation
- Seal Strength Testing Coordination
- Package Integrity Testing
- Accelerated and Real-Time Aging Studies
- Distribution Simulation Testing
7 deliverablesTalk to an expert about EN ISO 11607International
ISO 9001
Quality Management System (QMS) Implementation
- Quality Manual and SOP Preparation
- Document Control System
- Internal Quality Audits
- Corrective and Preventive Action (CAPA)
- Supplier Quality Management
- Certification Readiness Assessment
7 deliverablesTalk to an expert about ISO 9001United States
21 CFR Part 820 — FDA QMSR
FDA QMSR Gap Assessment
- ISO 13485–QMSR Compliance Mapping
- Design Control Documentation
- Complaint Handling Procedures
- CAPA System Implementation
- FDA Inspection Readiness
- QMSR Transition Support
7 deliverablesTalk to an expert about 21 CFR Part 820 — FDA QMSRInternational
ISO 13485
Medical Device QMS Gap Assessment
- Medical Device QMS Implementation
- Quality Manual and SOP Preparation
- Design and Development Controls
- Supplier Qualification and Evaluation
- Internal Audits and CAPA
- Certification Readiness Support
7 deliverablesTalk to an expert about ISO 13485International
ISO 14644
Cleanroom Classification
- Cleanroom Classification
- Cleanroom Qualification
- Airborne Particle Count Testing Coordination
- HVAC and Pressure Differential Review
- Environmental Monitoring
- Cleanroom Requalification
- Contamination Control SOP Preparation
7 deliverablesTalk to an expert about ISO 14644International
ISO 11135 — EO Sterilization
EO Sterilization Gap Assessment
- Sterilization Validation Protocol
- Sterilization Cycle Validation Support
- Microbiological Testing Coordination
- EO Residual Testing Coordination
- Routine Sterilization Process Control
- Requalification
7 deliverablesTalk to an expert about ISO 11135 — EO SterilizationInternational
ISO 11137 — Radiation Sterilization
Radiation Sterilization Validation
- Sterilization Dose Establishment
- Bioburden Assessment Coordination
- Sterility Testing Coordination
- Dose Mapping Study Coordination
- Routine Dose Audit
- Radiation Sterilization Requalification
Launch packages from 1/10th standard market pricing with accelerated timelines.
Book a Free Consult – Contact us today!
Regulatory Frameworks
Key medical device frameworks we support:
| Region | Framework | Authority |
|---|---|---|
| European Union | EU MDR 2017/745, IVDR 2017/746 | Notified bodies and national authorities |
| USA | 21 CFR (including Part 820 QMSR) | FDA |
| India | Medical Devices Rules, 2017 | CDSCO |
| International |
| Standards used across all regions |
Global Market Expertise
Expertise in Class I, II, and III Medical Device Regulatory Submissions and Market Access across global markets.
- CE MarkingEU
Device ScopeClass I, IIa, IIb, III - FDAUSA
Device ScopeClass I, II, III - PMDAJapan
Device ScopeClass I, II, III, IV - ANVISABrazil
Device ScopeClass I, II, III, IV - CanadaHealth Canada
Device ScopeClass I, II, III, IV - TGAAustralia
Device ScopeClass I, IIa, IIb, III - CDSCOIndia
Device ScopeClass A, B, C, D
Our Compliance Support
Beyond Standards, Toward Better Outcomes
We help you not only meet regulatory standards but also build a strong compliance foundation for long-term success.
- Gap Assessments
- Audit Preparation & Support
- Corrective Action & Remediation Strategy
- Documentation Review & Peer Review
- Post-Market Surveillance & Regulatory Updates
AUDIT-READY DOCUMENTATION
Structured, Compliant,
and Future-Ready
Our documentation support ensures your submissions are complete, accurate, and aligned with the latest regulatory expectations.
What You Gain
- Faster Time-to-Market
- Reduced Non-Compliance Costs
- Submission-Ready Technical Files
- Strengthened QMS Foundation
- Scalable Resource Support
Why It Matters
Compliance with global standards not only ensures regulatory approval but also improves product quality, patient safety, and business growth.
- Quality Products
- Patient Safety
- Global Market Access
PRICING & OFFER •
Launch packages from 1/10th standard market pricing with accelerated timelines.
Book a Free Consult – Contact us today! Our experts are ready to guide you through global regulatory requirements and help you bring innovative products to market.