Navigate your medical device to market — India, Europe & the US.
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.
Three pillars. One compliance partner.
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
Product-specific features & evaluations
- Electrical safety & essential performance per IEC/EN 60601 family (medical electrical equipment)
- Safety of laboratory & measurement equipment per IEC/EN 61010 series
- EMC, usability and associated collateral & particular standards
- Risk management files aligned to ISO 14971
- Test planning, accredited-lab liaison & evidence review
Process
Enterprise-wide certifications
- ISO 13485 — medical device quality management systems
- ISO 9001:2015 — foundational QMS for procurement & enterprise buyers
- ISO 45001 — occupational health & safety management
- Gap analysis → documentation → training → internal audit → certification
- Embedded support through Stage 1 & Stage 2 audits
Regulatory
Approvals & submissions to authorities
- CDSCO licensing under India's Medical Device Rules 2017
- CE marking via EU Notified Bodies under EU MDR
- US FDA premarket notification — the 510(k) pathway
- Device classification, predicate & pathway strategy
- Submission preparation, query response & authority liaison
Three markets, three regulators, one roadmap.
We focus on the approvals that matter most to India-based medtech startups — starting at home, then expanding abroad.
India · CDSCO
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.
Europe · CE Marking
Conformity assessment under the EU MDR through Notified Bodies — technical documentation, ISO 13485 alignment, and the safety & performance evidence behind the CE mark.
United States · FDA 510(k)
Premarket notification via the 510(k) channel — predicate identification, substantial-equivalence strategy, testing per FDA-recognised consensus standards, and submission support.
An embedded partner, not a one-off auditor.
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.
Gap Analysis & Diagnosis
Month 1On-site assessment against every applicable requirement; written gap report, scope, and risk & opportunity register.
Design & Documentation
Months 1–2Quality Manual, SOPs, work instructions and forms fitted to your real processes — not generic templates.
Training
Months 2–3Staff awareness sessions, certified internal-auditor training, and a focused top-management briefing.
Implementation Support
Months 3–4On-site and remote rollout guidance with evidence review against each clause of the standard.
Internal Audit & Mock Audit
Month 5Full internal-audit cycle, CAPA closure, and a mock audit simulating the certification body's Stage 2 assessment.
Certification & Liaison
Month 6Certification-body selection, application, and support through Stage 1 & Stage 2 — including closure of minor NCs.
Built for teams who need compliance that's real, lived and defensible.
- Medical-device and IVD / diagnostics startups preparing for market or CDSCO licensing
- Healthtech and connected-device companies asked for ISO certification by hospital or enterprise buyers
- Contract manufacturers and component suppliers entering medtech supply chains
- Deep-science spinouts commercialising lab innovations who need quality discipline as they scale
Not your typical consultant.
| 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 |
The people behind COMPASS.
Operators and domain experts from IKP Knowledge Park — regulatory, quality, manufacturing and programme leadership under one roof.
Karthik Venkataraman
Lead, IKP COMPASS
Dr. Satya Prakash Dash
CEO, IKP Knowledge Park
Dr. Sridhar Ramanathan
SVP, IKP Knowledge Park
Shreyas Kudva
Manufacturing Lead
Apoorva Bhatnagar
Senior Manager
Aaqib Jameel
Senior Manager
Padmaja Konisetti
Communications Manager
Dr. Riya Sarkar
Manager Strategy
Anuradha Barua
Legal Counsel, IKP
Frequently asked questions
What is IKP COMPASS?
Who requires ISO 9001 or ISO 13485?
At what stage should we engage?
What does a product evaluation involve?
How long does certification take?
Do you guarantee certification or approval?
What IKP needs from the entity signing up for the engagement?
How are fees structured?
Start with a short conversation.
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