Where engineering meets regulatory meets clinicians .
One accountable team across design, regulation, and testing.
Regulatory work isn’t paperwork!
It’s insurance against catastrophic loss — recalls, rejections, delays, and liability.
At 60601Consult, We make judgment calls that save you from million-dollar mistakes. We work with Indian startups and global medtech teams where engineering, quality, and regulation intersect. Whether you’re launching your first device or scaling globally, we take ownership from product design through regulatory clearance — without the usual delays, rework, or confusion.
One accountable team across design, regulation, and testing.
From CDSCO approvals (MD-42, Import, Class A/B/C/D) to CE Marking and US FDA 510(k) submissions, we manage the full journey:
✅ Approval-safe design, risk management & testing strategy
✅ ISO 13485 QMS implementation & audit readiness
✅ Regulatory submissions, agency responses & follow-ups
No form-filler shortcuts. Just expert execution where it matters most.
what our clients say!
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“Very professional, easy to work with and gets the job done.”
- Monir El Azzouzi
Easy Medical Device
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“They go the extra mile.”
- Prof. Iris Quasar Grunwald
University of Dundee | co-founder of Brainomix Ltd. and Nvention Ltd.
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“It all begins with an idea. Maybe you want to launch a business.”
Lindsey Beumer
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“It all begins with an idea. Maybe you want to launch a business.”
Keith Finley
Contact us.
Everything Medtech
Growing Innovative products are hitting the market every day, and there’s a strong need to understand the risks and benefits of the devices. Regulations help us do just that, and we help make understanding the regulations much more easier!