Global regulatory success,
for medical devices.
Harmoni Regulatory Services helps manufacturers navigate medical device regulation worldwide — from classification and strategy to technical documentation and market registration. Accredited laboratory testing is delivered through our sister laboratory, Harmoni Analyticals.
Regulatory Authority
🇺🇸 United States — FDA
510(k), De Novo, PMA, and Q-Submission strategy with UDI and post-market reporting.
Explore pathwayStandards & Compliance Alignment
OECD GLP Certified Laboratory
via Harmoni Analyticals
NABL Accredited Testing
via Harmoni Analyticals
ISO 13485-Aligned QMS
ISO 10993 Biocompatibility
ISO 14971 Risk Management
MDSAP-Ready Processes
Your Global Regulatory Partner
Multi-region expertise. End-to-end accountability.
One partner across FDA, EU MDR, MHRA, Health Canada, TGA and CDSCO — combining regulatory specialists, medical writers and toxicologists, with accredited laboratory testing through our sister laboratory.
Multi-Region Coverage
One partner across FDA, EU MDR, MHRA, Health Canada, TGA and CDSCO.
Regulatory + Scientific
Regulatory strategists, medical writers and toxicologists working as one team.
Accredited Lab Access
Testing delivered through our OECD GLP Certified, NABL Accredited sister lab.
End-to-End Accountability
A single point of contact from classification to post-market compliance.
Service Categories
Four practices. One accountable partner.
Regulatory, clinical, quality and laboratory experts working from one playbook — so handoffs disappear and your timeline holds.
Laboratory Services
Biocompatibility, chemistry and E&L via Harmoni Analyticals.
- Biocompatibility (ISO 10993)
- Chemical Characterization
- Extractables & Leachables
Consulting + Accredited Laboratory
Regulatory expertise, backed by an accredited sister laboratory.
Harmoni Regulatory Services handles regulatory strategy and submissions in-house. When your programme needs testing data, it is generated at our sister laboratory, Harmoni Analyticals — giving you science and regulation under one roof.
Harmoni Regulatory Services
In-house regulatory consulting
- • Classification & regulatory strategy
- • Technical documentation & submissions
- • Toxicological risk assessment & medical writing
- • Registration & post-market compliance
Harmoni Analyticals
Sister laboratory · OECD GLP Certified · NABL Accredited
- • Biocompatibility evaluation (ISO 10993)
- • Chemical characterization (ISO 10993-18)
- • Extractables & leachables studies
- • GLP analytical testing
Services
A complete regulatory operating system.
Device Classification
Know your risk class before you invest in a pathway.
Learn moreRegulatory Strategy
A pathway that aligns approval with your commercial goals.
Learn moreTechnical Documentation
Files that withstand Notified Body and FDA scrutiny.
Learn moreDevice Registration
End-to-end submission and registration management.
Learn moreMedical Writing
Clinical and scientific writing built for regulators.
Learn moreIn-Country Representative
Local legal presence in the markets you enter.
Learn moreRegulatory Compliance & QMS
Stay audit-ready across the product lifecycle.
Learn moreGlobal Market Access
Enter multiple markets in the right order.
Learn moreGlobal Regulatory Coverage
Hover the map to explore regulatory pathways.
Expertise across FDA, EU MDR, MHRA, Health Canada, TGA and CDSCO — integrated with in-country representation and lifecycle support.
9 Key Regions
In-Country Reps
One Partner
Regulatory Authority
🇺🇸 United States — FDA
510(k), De Novo, PMA, and Q-Submission strategy with UDI and post-market reporting.
Explore pathwayWhy Harmoni
Built for enterprise scale. Tuned for novel devices.
Regulatory Depth
Specialists across FDA, EU MDR, MHRA, Health Canada, TGA and CDSCO.
Accredited Lab Access
GLP/NABL testing delivered through our sister laboratory, Harmoni Analyticals.
Scientific Expertise
Toxicological risk assessment and biological safety interpretation under ISO 10993.
Regulatory Writing
CERs, technical files and scientific summaries structured for review.
End-to-End Delivery
From classification and documentation to registration and post-market support.
Single Accountability
A dedicated point of contact managing your programme end to end.
Our Process
Your regulatory journey, simplified.
Device Assessment
Intended use, technology and risk profiling across target markets.
Classification Review
Cross-jurisdiction class mapping and predicate analysis.
Regulatory Strategy
Pathway selection, evidence plan and milestone roadmap.
Documentation
Technical files, CERs, risk management and labelling.
Submission & Registration
Authority filings, representative appointments and query responses.
Compliance & Lifecycle
Post-market surveillance, vigilance and lifecycle support.
Get Started
Tell us about your device and target markets.
Share your device and regions of interest and our team will respond with a tailored regulatory outline within two business days.