IKP COMPASS is a hands-on compliance partner for medtech startups: product safety evaluations, enterprise quality certifications, and regulatory submissions with CDSCO, EU Notified Bodies and the US FDA — without your founding team having to become compliance experts first.
Market access is never a single certificate — it's the product, the processes behind it, and the regulatory file that ties them together. COMPASS covers all three under one engagement.
Product-specific features & evaluations
Enterprise-wide certifications
Approvals & submissions to authorities
We focus on the approvals that matter most to India-based medtech startups — starting at home, then expanding abroad.
Licensing under the Medical Device Rules 2017 — device classification, manufacturing & import licences, and the quality system evidence CDSCO expects. Our home turf and primary focus.
Conformity assessment under the EU MDR through Notified Bodies — technical documentation, ISO 13485 alignment, and the safety & performance evidence behind the CE mark.
Premarket notification via the 510(k) channel — predicate identification, substantial-equivalence strategy, testing per FDA-recognised consensus standards, and submission support.
Our flagship certification engagements run as a structured six-phase programme over six months — with defined deliverables at every milestone, and us in the room when the auditor or regulator arrives.
On-site assessment against every applicable requirement; written gap report, scope, and risk & opportunity register.
Quality Manual, SOPs, work instructions and forms fitted to your real processes — not generic templates.
Staff awareness sessions, certified internal-auditor training, and a focused top-management briefing.
On-site and remote rollout guidance with evidence review against each clause of the standard.
Full internal-audit cycle, CAPA closure, and a mock audit simulating the certification body's Stage 2 assessment.
Certification-body selection, application, and support through Stage 1 & Stage 2 — including closure of minor NCs.
| Typical consultant | IKP COMPASS |
|---|---|
| Drops a document pack, leaves | Embedded through implementation, internal audit and the certification audit itself |
| Generalist across industries | Medtech, medical devices, diagnostics & healthtech in India |
| ISO clauses only | ISO plus CDSCO / MDR 2017, FDA & EU pathway depth and clinical-validation awareness |
| Generic templates | Procedures fitted to your real processes and evidence trail |
| Audit support optional / extra | Mock audit plus on-call presence at Stage 1 & Stage 2 included |
Operators and domain experts from IKP Knowledge Park — regulatory, quality, manufacturing and programme leadership under one roof.
Lead, IKP COMPASS
CEO, IKP Knowledge Park
SVP, IKP Knowledge Park
Manufacturing Lead
Senior Manager
Senior Manager
Communications Manager
Manager Strategy
Legal Counsel, IKP
We'll discuss your product, your buyers and your regulatory horizon — then recommend the right first step, whether that's a safety evaluation, ISO certification, or a submission strategy for CDSCO, CE or FDA 510(k).
Prefer email? Write to us directly:
✉ Email IKP COMPASS