Solutions
Certification / Market Access Quality & Training Build a Device With Us Clinical & Post-Market
Testing
Lab Services Test Planning Test Coordination Test Report Review
Company
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Medical Device Development · Testing · Market Access

Build it.
Test it.
Bring it to market.

Medical device engineering, regulatory affairs, and testing — from development to submission. We work on the technical and regulatory problems that hold devices back from market.

Start a Project  → Explore Solutions
The MedTech Journey
Product Development
Risk & Compliance
Testing & Verification
Quality Systems
Certification & Market Access
Post-Market Surveillance
IEC 60601 · ISO 13485 · ISO 14971 · EU MDR · FDA
You could say…
"We are to MedTech
what Col. Sanders is to chicken."
MedTech is all we do.
Solutions

Everything a medical device
needs to reach the market.

01
Certification &
Market Access
CDSCO, BIS, CE Mark, FDA — each market has its own framework and its own failure modes. We prepare submissions that move.
CDSCO BIS CE / EU MDR FDA 510(k) Global
02
Quality &
Training
ISO 13485 QMS implementation, internal audits, CAPA, and managed RA/QA. Quality infrastructure that works day-to-day, not just on audit day.
ISO 13485 QMS Audits & CAPA Training
03
Technical
Development
Build a Device With Us, Turnkey Development, or Specific Consulting — IEC 60601-series, ISO 14971, IEC 62304, IEC 62366. Engineering expertise with regulation built in.
Build With Us Turnkey V&V IEC 62304
04
Clinical &
Post-Market
Clinical evaluation reports that hold up under notified body scrutiny. Post-market surveillance that's a real process, not a document in a folder.
CER / CEP PMS / PMCF Vigilance Biocompat
Testing

The right tests, run right.

Testing shouldn't be a bottleneck. We plan, coordinate and review medical-device testing — working with qualified laboratories to keep your timeline and your certification on track.

Lab Services
The right lab for the right test. We identify and qualify accredited testing laboratories and manage the relationship so your device gets tested correctly the first time.
Test Planning
Determine applicable standards, test methods, required samples, acceptance criteria and the optimal testing sequence for your device and certification pathway.
Test Coordination
We manage the moving parts of your test programme — lab scheduling, sample logistics, progress tracking, and issue escalation — so delays don't cascade.
Test Report Review
Already have test reports? We review them against your certification requirements, identify gaps and confirm whether they support your intended market access pathway.
Testing Capabilities
Electrical Safety (IEC 60601) EMC Environmental Mechanical / IP Biocompatibility (ISO 10993) Usability (IEC 62366) Software (IEC 62304)
Why 60601Consult

Specialists.
Not generalists.

Most regulatory consultants offer a broad menu of advisory services. We do something different: we're a specialist medical-device firm where every engagement draws on engineering depth, not just paperwork expertise.

Our team has worked across device classes, regulatory jurisdictions and the full product lifecycle — which means we've seen where projects go wrong, and we know how to keep yours on track.

IEC
60601 is in our name — not by accident
0
Industries other than MedTech
CDSCO
FDA · CE · BIS — we work in your market
E2E
Concept to post-market — one firm
  • Engineering-led
    We understand your device technically, not just its documentation requirements. That makes a real difference when problems arise.
  • End-to-end capability
    From first concept to post-market surveillance — you won't outgrow us. One relationship, across the full device lifecycle.
  • Global reach
    CDSCO, CE/EU MDR, FDA and beyond. We work with device companies wherever they are and wherever they want to sell.
  • Direct access
    You work directly with experienced people, not junior consultants who escalate every question. Fewer handoffs. Faster answers.
  • Practical execution
    We don't just advise — we deliver. Documents, submissions, strategies and training that regulators and auditors accept.
Rishabh Kumar
Rishabh Kumar
Founder & Principal Consultant
IEC 60601 ISO 13485 LA CDSCO EU MDR
About

Built for MedTech.
Only MedTech.

60601Consult was founded on a simple premise: medical device companies deserve a specialist, not a generalist. The regulatory and engineering landscape for medical devices is demanding enough — your consulting partner should genuinely understand it.

We work with manufacturers, importers, startups and established companies navigating new markets. Whether you need a single certification, a quality system built from scratch, or a device developed from concept to market — we've done it before.

Specialist medical-device consulting — not a division of a broader firm
Deep expertise in IEC 60601, ISO 13485, ISO 14971 and EU MDR
Clients across India, Europe, Southeast Asia and the Middle East
Engineering background — not just regulatory paperwork
Markets Served
🇮🇳 India / CDSCO 🇪🇺 Europe / EU MDR 🇺🇸 USA / FDA 🇬🇧 UK / UKCA 🇦🇺 Australia / TGA 🌏 Southeast Asia 🇦🇪 Middle East 🌐 Global
Start a Project

Have a medical device?
Let's talk.

Tell us where you are in the process — concept, development, testing or certification. We'll tell you what you need and how we can help.

Start a Project → contact@60601consult.com