BIOCOMPATIBILITY TESTING
MRIDA offers a complete battery of biocompatibility studies for all classes of medical devices (ISO 10993, ISO 7405, ISO 11979)
HEMOCOMPATIBILITY
- Hemolysis Test
- Complete Blood Count
- Prothrombin Time Test (PT)
- Partial Thromboplastin Time (PTT)
- Complement Activation (C3a, SC5b-9)
- Platelet Aggregation
TOXICITY
- Acute Systemic Toxicity
- Chronic & Subchronic Toxicity
- Reproductive Toxicity
- Carcinogenicity
CYTOTOXICITY
- Agar Diffusion
- MEM Elution
- MTT
GENOTOXICITY
- Bacterial Reverse Mutation
- Micronucleus Test
- Chromosomal Aberration
- Mouse Lymphoma
IMPLANTATION
- IM & SC Implantation
- Bone Implantation
- Dental Implantation
- Stent Implantation
- Contact Lens Implantation
SENSITIZATION
- Maximisation Test (GPMT)
- Closed Patch Test (Buehler)
- Local Lymph Node Assay (LLNA)
IRRITATION
- Dermal
- Intracutaneous
- Ocular
- Oral Mucosa
- Penile
- Rectal
- Vaginal Irritation
PYROGENICITY
- In vivo Pyrogen Test
- In vitro Bacterial Endotoxin Test (LAL Test)
PRE-CLINICAL SERVICES
MRIDA offers preclinical services for performance, biocompatibility & safety evaluation of medical
devices and therapeutics (ISO 10993, ISO 25539-2: 2012 and 21 CFR 58 / GLP) in the following segments:
CARDIOVASCULAR DEVICES
- Cardiac Rhythm / Flow Management Devices (Defibrillator & Pacemaker)
- Interventional Cardiac Devices (Stents, Catheters & Angioplasty Balloons)
- Cardiac Monitoring / Diagnostic Devices (Telemetry Systems)
- Peripheral Vascular Devices (Stents, Grafts & Balloon Catheters)
- Prosthetic Devices and Ventricular function devices (Prosthetic Valves & VAD)
GASTROINTESTINAL SEGMENT DEVICES
- Nasogastric Tubes, etc.
GENITOURINARY SEGMENT DEVICES
- Urinary incontinence devices (macroplastique, urethral sling implants & nephrostomy tubes / urinary stents)
NEUROLOGICAL SEGMENT DEVICES
- Neuroplast implants
- Renal Denervation ablation devices, etc.
DENTAL DEVICES
- Endosteal / Endosseous
- Single-Stage and subperiosteal dental implants
INTEGUMENTARY IMPLANT DEVICES / THERAPEUTICS
- Hemostats & Sealants nats and cellular implant therapies for wound healing
ORTHOPEDIC SEGMENT
- Tissue engineered grafts for bone defects
- Knee replacement implants (Metal and Ceramic implants)
STANDALONE SERVICES
Palamur Bio’s standalone services offer an extended support for the discovery phase of device development as well as for the regulatory submissions. Our scientific expertise provides the customization of these services as per the client’s need. The cost effectiveness and quick turnaround time is the forte of our services.
HISTOPATHOLOGY SERVICES
- Histopathological evaluation of tissue samples with implanted medical devices using Resin embedding and diamond cutter
IMMUNOHISTOCHEMISTRY (IHC) SERVICES
- IHC for implant devices to evaluate the specific changes at implantation site
EFFICACY ASSESSMENT FOR
MEDICAL DEVICES
MEDICAL DEVICES
- Microbial Ingress Test
- Bone regeneration / growth
INDIA
Mahbubnagar, Telangana, India
© Palamur Bio 2020.
All rights reserved
USA
Dr. P. Srinivas Reddy, Ph.D.,
Palamur Biosciences Inc,
9841 Washington Blvd,
Suite 200,Gaithersburg, Maryland 20878, USA.
Palamur Biosciences Inc,
9841 Washington Blvd,
Suite 200,Gaithersburg, Maryland 20878, USA.
