Who We Are?
We are a leading Total Quality Assurance provider specializing in the field of medical devices industry worldwide. We are one stop solution for inspections, trainings, CE marking, ISO certifications & testing of electrical & electromedical products. We provide customized solutions to help you achieve and effectively maintain your regulatory and commercial success.
Our Services
EU Authorised Representative
We monitor vigilance issues related to your product and are the contact person on your behalf for European Authorities
UK Responsible Person & MHRA Registration
As UK Responsible Person we act on behalf of the manufacturer under UK MDR 2019 & do registration in MHRA
US FDA Agent & Registration
We do product registration for both 510K exempt and 510K products with US FDA along with FDA audit compliance services
Free Sales Certificate
We provide FSC from EU and UK for medical devices with apostille, notarization and legalisation services
Trainings
We provide knowledge based interactive trainings for ISO 9001:2015, ISO 13485:2016, ISO 14971:2019, UDI and other related topics
Consultancy
Our services cover CE marking & testing for medical devices in addition to standards like ISO 13485, ISO 9001, ISO 14971 etc.
Our Clients
Some of our most reputed clients include names like
Healthium Medtech
Tynor Orthotics
Unisur Lifecare
SPM Medicare
Become Our Client TODAY!!
We are a ONE STOP SOLUTION for all your medical device’s needs and problems.
We help you in achieving:
- Testing and certification for faster regulatory approval
- Total Quality Assurance across your supply chain
- Rapid & efficient entry to virtually any market in the world
- Innovative leadership in meeting social accountability standards
- Name and fame as a trusted and assured brand in the market
- Increased Product demand and overall profit