Mavens offer cutting-edge medical device testing services that adhere to GLP and ISO 10725 guidelines. The studies required for the device will be suggested by subject matter experts in each sector for medical devices.
We support your orthopaedic, dental, ophthalmology, cardiovascular, respiratory, PPEs, and other preclinical medical device testing programmes with our knowledge of ISO and FDA medical device regulations.
We regularly assess biocompatibility in accordance with ISO 10993. We are an ISO 17025 recognised laboratory with OECD GLP certification. The Mavens data has been favourably received by the USFDA (for 510K and PMA), the EU (for CE Marking), and other regulatory bodies. Mavens’ clients come from India, the United Kingdom, France, the United States, Canada, Brazil, Malaysia, Germany, Australia, China, Norway, Saudi Arabia, Thailand, Indonesia, Switzerland, Japan, and the Rest of the World.
Following tests are routinely conducted in our laboratory.
Cytotoxicity Test
Qualitative tests
MEM Elution
Agar Overlay Assays
Direct Contact Test
Quantitative tests
MTT Assay
XTT Assay
Neutral Red Uptake (NRU)
Colony Formation
Irritation Test
Primary Skin Irritation Test
Intracutaneous Reactivity Test
Ocular Irritation Test
Mucosal / Special Irritation Test (Oral, Rectal, Vaginal & Penile)
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