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Medical Device Services

| Medical Device Services

Sipra is the single stop solution service provider for the medical devices testing from its development stage to delivery to the consumer in compliance to the global regulatory requirements.

State of the art facility with broad testing capabilities, dedicated team of expert scientists, unsurpassed technology and innovation have carved Sipra as preferred destination for the medical device manufacturers, for their device research and developmental testing needs.

Sipra’s medical device research and developmental team has the expertise in solving the unique challenges of device development and providing precise regulatory solutions as per all major global regulatory agencies to bring out new devices in to the market. The team has the expertise in developing the protocols and study designs for the testing of various classes of medical devices from low to high risk level as per respective regulatory classification.

Sipra is offering services in device testing to meet its regulatory, toxicology, chemistry, clinical, microbiology and quality needs through its innovation and expertise.

We are specialized in testing of Catheters, Stents (Cardio vascular, Drug eluting, Orthopaedic and Gastro) and other devices such as hypodermic needles, syringes, tubal rings and Copper-T.

Sipra is the unique place for widespread testing of devices classified under respective global regulatory agency by its level of risk from low to high and offering the following services.

  • OECD GLP compliant Biocompatibility testing of medical devices as per ISO 10993
  • Chemical testing of devices as per ISO
  • NABL ISO 11607 compliant packaging material testing of the devices
  • Mechanical Testing of medical devices as per ASTM

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