Medical Device Testing Services

Bioneeds provides state-of-the-art testing services for medical devices under GLP and ISO 10725 standards. The subject matter experts in every field for medical devices will suggest the studies required for the device.

With expertise in ISO and FDA medical device regulations, we support for your orthopedic, dental, ophthalmic, cardiovascular, respiratory, PPEs, and other preclinical medical device testing programs.

We routinely evaluate biocompatibility as per ISO 10993. We are OECD GLP certified and ISO 17025 accredited Laboratory. The data generated at Bioneeds has been well accepted by USFDA (for 510K & PMA), EU (for CE Marking) and other regulatory agencies. Bioneeds clientele includes National and International companies from India, UK, France, US, Canada, Brazil, Malaysia, Germany, Australia, China, Norway, Saudi Arabia, Thailand, Indonesia, Switzerland, Japan & ROW

Mutagenicity Lab

Following tests are routinely conducted in our laboratory.

Cytotoxicity Test

Qualitative tests

Quantitative tests

Irritation Test

Skin Sensitization Tests

Systemic Toxicity Tests

Hemocompatibility Tests

Pyrogenicity Tests

Implant Tests

Plastics Testing

Others

Genotoxicity Testing

Biological Safety Evaluation

Regulatory Guidelines