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RNCS & Tech Services LLP is a regulatory affairs consultancy for the medical device industry. The company helps MedTech innovators navigate CE Marking, FDA 510(k) clearance, ISO 13485, MDSAP Audit and related compliance strategies.
What they do:
- US market: 510(k) submissions, FDA pre-submission meetings, De Novo classification, and PMA support
- Europe: CE Marking under EU MDR/IVDR, technical documentation, Clinical Evaluation Reports (CERs), and post-market surveillance
- MENA region: SFDA (Saudi) approval, GCC certification, and local authorized representative services
- APAC: Registration support for China's NMPA, India's CDSCO, Japan's PMDA, and Australia's TGA
- QMS: Quality management system consulting and implimentation support
The firm is based in Kakkanad, Kerala, India
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Min project size
Undisclosed
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Hourly rate
$25 - $49 / hr
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Employees
2 - 9
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Locations
Kakkanad, India
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Year founded
Founded 2023
1 Locations
- Kakkanad , India
Service Lines
- Compliance Consulting
- 60%
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Industries
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Clients
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