Navigate Every Market. Clear Every Audit.

Regulatory strategy embedded in engineering — not bolted on at the end. Every design decision we support is informed by FDA, CE, and CDSCO requirements before a single prototype is built.

Regulatory Affairs & Compliance Consulting

The Problem We Solve

Regulatory delays are the leading cause of missed market windows in medical device development. Most companies treat compliance as a final gate — we treat it as a design input. Every engineering decision we support is informed by FDA, CE, and CDSCO requirements before a single prototype is built. The result is a device that does not need to be redesigned for regulatory reasons.

What We Do

Four regulatory disciplines — embedded in your engineering process, not layered on top of it.

🇺🇸 FDA Pathway Strategy & Submissions

Device classification and predicate analysis
510(k) premarket notification preparation and submission
PMA and De Novo application support
Pre-submission (Q-Sub) meeting preparation with FDA
Technical file compilation, review, and gap assessment

🇪🇺 CE Marking — EU MDR 2017/745

EU MDR classification and conformity route selection
Technical documentation and Notified Body coordination
Clinical Evaluation Report (CER) and PMCF plan preparation
EUDAMED registration support
Post-Market Surveillance plan aligned to EU MDR Annex III

🇮🇳 CDSCO India Registration

Class A, B, C, and D device registration
Import and manufacturing licence support
CDSCO dossier preparation and submission management
Alignment to Medical Devices Rules 2017 and amendments
Liaison management with CDSCO throughout the approval process

🔍 Audit Readiness & Regulatory Remediation

Pre-inspection readiness assessment
Mock FDA, Notified Body, and CDSCO audits
Observation response preparation: Form 483, Warning Letter
CAPA development, implementation, and verification of effectiveness
Documentation gap analysis and structured remediation

Who This Is For

We work with device companies at every regulatory stage — first submission to multi-market expansion.

Startups filing their first regulatory submission and needing a structured approach

International companies entering India requiring CDSCO registration for the first time

Device companies expanding from one regulatory jurisdiction to multiple simultaneously

Firms that have received regulatory observations and need structured remediation

Companies preparing for a Notified Body or FDA inspection

Why 369 Innovations

Our regulatory team works inside the same engineering environment that builds your device — not in a separate consulting silo. This means your submission accurately reflects your product, your technical file is traceable to real design outputs, and your timeline does not slip because regulatory was an afterthought.

Key Differentiator: Regulatory support built into the engineering process — not added when the device is already built.