Medical Device Testing Services
GLP & ISO 17025 Accredited Laboratory for Global Regulatory Compliance
Adita Biosys provides comprehensive medical device testing services under GLP and ISO/IEC 17025 standards, ensuring accurate, reliable, and regulatory-compliant results. Our laboratory operates in accordance with OECD GLP and US FDA 21 CFR Part 58 GLP requirements, delivering high-quality data accepted by global regulatory authorities.
Standards & Regulatory Compliance
Our testing programs comply with internationally recognized standards and guidelines, including:
- ISO 10993 Series
- ASTM Standards
- ASCA Program Requirements
- MHLW (Japan) Guidelines
- AAMI
- Product Specific ISO Guidelines
- Product Specific US FDA Guidance Documents
- Pharmacopoeia (USP / BP / IP)
We support submissions to:
- US FDA (510(k) & PMA)
- EU CE Marking (MDR)
- CDSCO (India)
- Global regulatory authorities
Accreditations & Certifications
Our laboratory is:
- OECD GLP Certified
- US FDA 21 CFR Part 58 GLP Compliant
- ISO/IEC 17025 Accredited by American Association for Laboratory Accreditation (A2LA)
- ISO/IEC 17025 Accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL)
Why Choose Adita Biosys?
- Regulatory-focused study design
- Experienced biological evaluation experts
- GLP-compliant quality systems
- Globally accepted test reports
- Timely project execution
END-TO-END
Biological Safety Evaluation for Medical Devices
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)
Skin Sensitization Tests
- Buehler Sensitization Method
- Guinea Pig Maximisation Test (Magnusson-Kligman)
- Local Lymph Node Assay (LLNA)
Systemic Toxicity Tests
- Acute
- Sub-acute
- Sub-chronic
- Chronic
Hemocompatibility Tests
- Hemolysis Test
- Partial Thromboplastin Time (PTT)
- Complement Activation (C3a & SC5b-9)
- Platelet Aggregation / Activation
- Leukocyte Activation Test
- Haematology Test
Pyrogenicity Tests
- In vitro Bacterial Endotoxins
- Material Mediated Rabbit Pyrogenicity Test
Implantation Studies
- Intramuscular
- Subcutaneous
- Bone
- Ocular Implantation
Plastics Testing
- In vitro Biological Reactivity Tests
- In vivo Biological Reactivity Tests
Others
- Carcinogenicity
- Reproductive Toxicity
- Teratogenicity
Genotoxicity Testing
- Bacterial Reverse Mutation (AMES) Test
- Mouse Lymphoma Assay
- In vitro & In vivo Micronucleus Test
- In vitro & In vivo Chromosomal Aberration
Biological Safety Evaluation
- Biological Evaluation Plan
- Chemical Characterization
- Toxicological Risk Assessment
- Biological Evaluation Report