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Integrated Discovery, Development and
Regulatory Services
BIOCOMPATIBILITY TESTING
OF MEDICAL DEVICES
Bioneeds routinely evaluates Biological safety for varied types of Medical
Devices as per ISO 10993. Data generated at Bioneeds has been well
accepted by USFDA (for 510K & PMA), EU (for CE Marking) and other
regulatory agencies. Our clientele includes national and international
companies viz. UK, France, US, Canada, Brazil, Malaysia, Germany,
Australia, China, Norway, Saudi Arabia, Thailand, Indonesia, Switzerland,
Japan and ROW.
Email: [email protected] | Website: www.bioneeds.in | Contact No. +91 9686793916
Cytotoxicity Tests Agar Overlay
MEM Elution
MTT Assay / XTT Assay
Neutral Red Uptake
Colony Formation
Systemic Toxicity Tests
Acute
Sub-acute
Sub-chronic
Chronic
Implant Tests
Intramuscular
Subcutaneous
Bone
Relevant Clinical Site (Ex: Intraperitoneal, Bone / Joint, Dental, Spine, Ocular and Calvarial)
Genotoxicity Tests Bacterial Mutation (AMES) Test
Mouse Iymphoma
In vitro & In vivo micronucleus
In vitro & In vivo chromosomal aberration
Irritation Tests Primary Skin Irritation
Intracutaneous Reactivity
Ocular Irritation
Mucosal Irritation (Oral, Rectal, Vaginal & Penile)
Hemocompatibility Tests Hemolysis Test
Prothrombin Time (PT)
Partial Thromboplastin Time (PTT / Inactive PTT)
Complement Activation (C3a & SC5b-9)
Platelet Aggregation / Activation
Coagulation
Thrombosis / Fibrinolysis
Leukocyte Activation
Plastics Testing Biocompatibility Tests for Classifications of Plastics (USP Class VI Test)
Medical Device Toxicity Risk Assessment
Sensitization Tests Buehler Sensitization Method
Maximization (Magnus-Kligman)
Local lymph Node Assay (LLNA)
Pyrogenicity Tests In vitro Bacterial Endotoxins
Material Mediated Rabbit Pyrogen Test
Others Carcinogenicity
Reproductive Toxicity
Teratogenicity
Immunotoxicity / Immunogenicity
Regulatory Guidelines ISO 10993
ASTM
US FDA
AAMI
Product Specific ISO Guidelines
Pharmacopoeia (USP / BP / IP)
BIOCOMPATIBILITY TESTING OF MEDICAL DEVICES
World class lab with cutting edge technology | Expert scientific team of 210 personnel
AAALAC Accredited Vivarium with
85 Exclusive Animal Rooms
10 Years of Contract Research Experience
GLP Accredited Preclinical Development Center
Devarahosahally, Sompura Hobli, Nelamangala Tq, Bengaluru Rural District-562111, Karnataka, INDIATel: +91 816-2214400Contact No.: +91 9844457677, 9686793916Email: [email protected], [email protected]: www.bioneeds.in
Chemistry & Biopharma R&D Facility
P-3, Peenya Industrial Area, 1st Main Road,
Peenya 1st Stage, Bengaluru-560058,
Karnataka, INDIA
Tel: +91 80-22658400
CONTACT US
