Division of Palamur Biosciences Private Limited Medical Research Institute for Devices Assessment
BACKGROUND MEDICAL RESEARCH INSTITUTE FOR DEVICES ASSESSMENT (MRIDA)
MRIDA, the innovative medical devices testing, and training division of Palamur Biosciences (PBS), is established under the aegis of Indian National Biopharma Mission (NBM) and Biotechnology Industry Research Assistance Council (BIRAC), India.
MRIDA is the first of its kind dedicated medical devices testing facility in private sector in India complying with various national and international quality systems such as OECD, GLP, ISO, AAALAC, CDSCO, and NABL using large animal models like swine dogs, sheep, etc.
The objective of MRIDA is to support the process improvement opportunities against a proven set of best practices to increase performance in addition to compliance and to improve the medical device manufacturing segment’s ecosystems.
Our Services
SAFETY AND PERFORMANCE EVALUATION OF MEDICAL DEVICES
MRIDA focusing on the implantable medical devices testing segment and using sophisticated surgical...
BIOCOMPATIBILITY & PRE‑CLINICAL SERVICES
MRIDA offers a complete battery of biocompatibility studies for all classes of medical devices (ISO 10993, ISO 7405, ISO 11979)...
CORE LABORATORY SERVICES & CLINICAL EVALUATION
In-house latest data processing systems which accept digital data in standard DICOM format for QCA...
STAFF ASSISTED
WET BENCH
TRAINING
Staff Assisted Wet Bench Hands on Education and Teaching Workshops covering all necessary fields...
SAFETY AND PERFORMANCE EVALUATION OF MEDICAL DEVICE
MRIDA focusing on the implantable medical devices testing segment and using sophisticated surgical...
BIOCOMPATIBILITY & PRE‑CLINICAL SERVICES
MRIDA offers a complete battery of biocompatibility studies for all classes of medical devices (ISO 10993, ISO 7405, ISO 11979)...
CORE LABORATORY SERVICES
In-house latest data processing systems which accept digital data in standard DICOM format for QCA and QVA using our test facility Angiography Suite...
STAFF ASSISTED WET BENCH TRAINING
Staff Assisted Wet Bench Hands on Education and Teaching Workshops covering all necessary fields...
OUR KEY EQUIPMENTS
The State of the Art 22,000 sq ft. facility with the following Key Equipments.
- Cathlab (Philips Azurion 3 M12)
- IVUS (Boston Scientific)
- OCT (St. Jude's Ilumien Optis)
- Cardiac Doppler (PHILIPS CX50)
- 2D & 3D Echo Cardiograph
- Ventilators / Physiological Monitors
- High End LEICA Microscope (LM Application suite)
- Cardio Pulmonary Bypass
- Defibrillators with Synch
- SEM (JEOL 0JSM-IT500HR InTouchScope™)
- HPLC and LCMS
OECD-GLP
The OECD principles of Good Laboratory Practice (GLP)
ISO 17025:2017
ISO certification for Testing & Calibration Laboratories
NABL
National Accreditation Board for Laboratories
AAALAC International
Association for Assessment and Accreditation of Laboratory Animal Care
CDSCO
Central Drugs Standard Control Organisation
CPCSEA
Committee for the Purpose of Control and Supervision of Experiments on Animals
SERVICESSAFETY AND PERFORMANCE EVALUATION OF MEDICAL DEVICES
MRIDA focusing on the implantable medical devices testing segment and using sophisticated surgical interventional facility / equipment broadly supports the following.
- Cardiovascular segment
- Gastrointestinal segment
- Genitourinary segment device
- Neurological segment
- Dental
- Integumentary implants / therapeutics
- Orthopedic related equipments
SERVICESBIOCOMPATIBILITY & PRE‑CLINICAL SERVICES
MRIDA offers a complete battery of biocompatibility studies for all classes of medical devices (ISO 10993, ISO 7405, ISO 11979) and preclinical services for performance & safety evaluation of medical devices and therapeutics (ISO 25539-2:2012 and 21 CFR 58) in the following segments.
- Toxicity
- Sensitization
- Cardiovascular
- Gastrointestinal
- Histopathology services
SERVICESCORE LABORATORY SERVICES
MRIDA Core Lab uses in-house latest data processing systems which accept digital data in standard DICOM format for QCA and QVA using our test facility angiography suite or specific formats such as 3D Echo cardiography, Optical Coherence Tomography (OCT), Intravenous Ultrasonography (IVUS) etc.
- Angiography
- Echocardiography (ECHO)
- Optical Coherence Tomography (OCT)
- Electrocardiogram (ECG)
- Intravascular Ultrasound (IVUS)
SERVICESCLINICAL EVALUATION REPORT SERVICES
Clinical evaluation is the assessment and analysis of clinical data pertaining to a particular medical device to verify its clinical safety and performance. The clinical evaluation is based on comprehensive analysis of pre-and post-market clinical data relevant to the intended use of the Medical Device.
Our Expertise
- End-to-end Clinical Evaluation Report (CER) writing
- Identify, search, analyze the appropriate scientific literature applicable to the manufacturer
- Developing regulatory complaint CER template
- Develop standard operating procedure to compile PMS data to update CERs
- PMS / PMCF data support for existing devices in the market
- Gap analysis and periodic update of existing CER
CONTACT USQuotation Request
INDIA
Mahbubnagar, Telangana, India
© Palamur Bio 2021.
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.
Services
Key Equipments
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