Consulting & Auditing

Turnkey Project Consultation
Market Research & Product feasibility, Initial evaluation of possible development of a medical device...
Regulatory Consultation, Registrations & Licenses
CDSCO, USFDA, UK, EUROPE, AUSTRALIA, BRAZIL, CANADA, JAPAN, CHINA
Documentation, Auditing & Certifications
ISO 9001, ISO 13485, ISO 14155, ISO 15189, ISO 11607, ISO 45001, ISO 14001, ISO 50001...
Testing & Assessment
Chemical, Biological, Mechanical, Clinical, Electrical, Software, Clinical Investigations, Pre- Clinical studies
Regulatory Intelligence
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Other Services
DSIR, MOFPI , LMPC Certification, EPR (e- Waste) Registration, US Agent, European authorized representative

About Us

What We Do
Who We Are
Industries We Serve
Vision & Mission

Trainings & Qualification

  • Indian Medical Device Regulations (IMDR)
  • Risk Management System for Medical Devices
  • US FDA Medical Device Regulations
  • ISO 13485:2016- Quality Management System for Medical Devices
  • EU MDR 2017/745 & 2017/746

300+

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30+

Top 100 R&D Spenders

15000+

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