About Harmoni Regulatory Services
Science and regulation, under one roof.
We are an international medical device regulatory consultancy. Our specialists guide manufacturers from classification through global registration and post-market compliance — supported by an accredited sister laboratory.
What we do
Regulatory strategy, device classification, technical documentation, medical writing, registration and post-market compliance across FDA, EU MDR, MHRA, Health Canada, TGA and CDSCO.
How we work
One accountable team and a single point of contact — combining regulatory specialists, medical writers and toxicologists so handoffs disappear and your timeline holds.
Harmoni Regulatory Services
The regulatory consultancy — strategy, documentation, submissions and compliance handled in-house.
Harmoni Analyticals
Our sister laboratory — OECD GLP Certified, NABL Accredited — delivering biocompatibility and analytical testing.
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.