beyond paperwork. into product success.
See how we help Medtech companies through our Mascots!
DocByteDocumentation and Risk ExpertDriving Indian and global medtech teams.
At 60601Consult, we work with Indian startups and global medtech teams to simplify complex regulations. Whether you're launching your first device or scaling up, we guide you from product design to regulatory clearance—without the usual delays or confusion.
From CDSCO approvals (MD-42, Import, Class A/B/C/D) to CE Marking and US FDA 510(k) submissions—we handle the full journey:
✅ Design, risk management & testing support
✅ ISO 13485 QMS implementation
✅ Regulatory submission & follow-ups
No form-filler shortcuts. Just expert execution.
Proto
product dev & testing buddyQ-Shield
Quality & ISO 13485 CoachRegi
Licensing & Auditing Guruwhat 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!