Medical Device Testing Services
Bioneeds provides state-of-the-art testing services for medical devices under GLP and ISO 17025 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
Qualitative tests
- MEM Elution
- Agar Overlay Assays
- Direct Contact Test
Quantitative tests
- MTT Assay
- XTT Assay
- Neutral Red Uptake (NRU)
- Colony Formation
- Primary Skin Irritation Test
- Intracutaneous Reactivity Test
- Ocular Irritation Test
- Mucosal / Special Irritation Test (Oral, Rectal, Vaginal & Penile)
- Buehler Sensitization Method
- Guinea Pig Maximisation Test (Magnusson-Kligman)
- Local Lymph Node Assay (LLNA)
- Acute
- Sub-acute
- Sub-chronic
- Chronic
- Hemolysis Test
- Partial Thromboplastin Time (PTT)
- Complement Activation (C3a & SC5b-9)
- Platelet Aggregation / Activation
- Leukocyte Activation Test
- Haematology Test
- In vitro Bacterial Endotoxins
- Material Mediated Rabbit Pyrogenicity Test
- Intramuscular
- Subcutaneous
- Bone
- In vitro Biological Reactivity Tests
- In vivo Biological Reactivity Tests
- Carcinogenicity
- Reproductive Toxicity
- Teratogenicity
- Bacterial Reverse Mutation (AMES) Test
- Mouse Lymphoma Assay
- In vitro & In vivo Micronucleus Test
- In vitro & In vivo Chromosomal Aberration
- Biological Evaluation Plan
- Toxicological Risk Assessment
- Biological Evaluation Report
- ISO 10993
- ASTM
- US FDA
- AAMI
- Product Specific ISO Guidelines
- Product Specific US FDA Guidance Documents
- Pharmacopoeia (USP / BP / IP)