Regulatory Strategy
Classification, pathway selection and predicate analysis — before you commit a single engineering hour.
PLANThe shortest defensible path to market.
Unplex® plans, builds and defends regulatory submissions and quality systems for active medical devices and combination products — monitoring, diagnostics, SaMD and digital health. One harmonized system, ISO 13485:2016 at the backbone, carried across US FDA, CDSCO, Health Canada and IMDRF-aligned markets. Most of our client relationships start right here.
ISO 13485:2016 — BACKBONE
US FDA
CDSCO — INDIA
HEALTH CANADA
IMDRF
COMBINATION PRODUCTS
IEC 62304
ISO 14971
01 — WHAT WE REGULATE
Active devices. Signal to decision.
Our home turf is the active device: sense a physiological signal, turn it into data, support a clinical decision. If that describes your product, it describes our practice.
D/01
Monitoring
Wearables, patient monitoring and electrotherapy — devices that measure the body and act on it.
D/02
Diagnostics
Point-of-care IVD and diagnostic instruments built on optics and electromechanics.
D/03
SaMD
Software as a Medical Device, developed and documented with IEC 62304 discipline.
D/04
Digital Health
Connected platforms and companion apps that move regulated data safely.
02 — WHAT WE TAKE OFF YOUR PLATE
Eight ways we carry the regulatory load.
Engagements start small — a classification question, a document review — and grow into a consistent partnership. Start anywhere.
Market Access & Approvals
FDA pathways including 510(k), CDSCO licensing and Health Canada submissions — sequenced for multi-market entry.
SUBMITIndia ↔ Global Access
Take an Indian device to the world — or a global device to India — on one harmonized quality system.
CROSS-BORDERQMS Implementation
ISO 13485:2016 systems — the processes, the documentation, the certification — built right, or rebuilt after a hard audit.
ISO 13485Technical Documentation
Technical files, dossiers, regulatory writing and submission-ready review of what you've already written.
DOCUMENTClinical Support
Clinical evaluation, investigation documentation and evidence planning that satisfies reviewers.
EVIDENCEPost-Market & Lifecycle
Surveillance, change management and post-approval obligations — managed, not feared.
MAINTAINStaff Augmentation
Embedded RA/QA capacity for your team — hands, not just advice — supplier audits included.
SCALE03 — OUR QARA DNA
Our QARA practice wasn't born in paperwork. It grew out of systems engineering — electronics, software, mechanics, manufacturing — across the full product lifecycle. We document devices the way engineers build them, so the technical file reads coherently to the reviewer and the auditor.
04 — HOW ENGAGEMENTS BEGIN
Start with fifteen minutes.
No discovery questionnaires, no proposals-by-the-kilo. Bring the question that's blocking you.
S/01
The 15-minute call
Bring the question. NDA first if you prefer — your IP stays yours either way.
S/02
Gap assessment
A fixed-scope review of where you stand: device class, documentation, QMS maturity.
S/03
Roadmap & execution
A sequenced plan with owners and dates — and we execute it alongside your team.
S/04
Lifecycle partnership
Most clients stay. Approval is a milestone, not the finish line.
05 — GLOBAL, BY DESIGN
India to the world.
The world to India.
Active devices cross borders on harmonized documentation. We build your quality system once — ISO 13485:2016 at the backbone, aligned to the IMDRF framework — so each new market is an increment, not a restart.
One quality system, every market
Deep working knowledge of US FDA, CDSCO and Health Canada, practiced on a quality system that IMDRF-aligned regulators worldwide recognize. The technical documentation you build for your first market becomes the foundation for the next — not a rewrite.
India to the world
US FDA pathway strategy and 510(k) submissions, EU MDR CE marking, Health Canada licensing and entry into IMDRF-aligned markets — take an Indian device global without rebuilding the file at every border.
The world to India
CDSCO classification and import licensing, authorized-agent guidance, local manufacturing and supplier evaluation — bring any device into one of the world's fastest-growing medtech markets. Supported from Bangalore.
06 — TRY THE FREE TOOLS FIRST
Some answers shouldn't cost anything.
Built from the questions our clients ask most. Use them, bookmark them — and when the answer raises the next question, you know where to find us.
Browse all tools →07 — QUESTIONS, ANSWERED
Asked on most first calls.
Which markets do you cover?+
Hands-on submission work across US FDA, CDSCO (India) and Health Canada. Beyond those, your ISO 13485:2016 system and IMDRF-aligned documentation carry into CE marking and other harmonized markets — we build the strategy and coordinate with local representatives where required.
Can you remediate a QMS after a failed audit?+
Yes — remediation is a core offer. We audit the gap, fix the system and the documentation, and prepare your team for the re-audit. Led by an ISO 13485:2016 QMS Lead Auditor.
Do you handle submissions end to end?+
Yes. Strategy, dossier and technical file preparation, submission, and the question-and-answer rounds with reviewers — through to approval and beyond.
Do you work on combination products?+
Yes — drug-device and biologic-device combinations are a core differentiator. We navigate the device–pharma interface: which regulatory framework leads, how one QMS satisfies both sides, and what each reviewer needs to see in the dossier.
We have an RA/QA team — how do you fit in?+
Two ways: as strategists for the decisions that carry risk, or as embedded capacity (staff augmentation) when your team needs more hands. Many clients use both at different stages.
READY WHEN YOU ARE
Book 15 minutes.OR WRITE TO INFO@UNPLEX.TECH