Division of Palamur Biosciences Pvt Ltd Medical Research Institute for Devices Assessment
BACKGROUND Medical Research Institute for Devices Assessment (MRIDA)
MRIDA is the medical devices testing and training division of Palamur Biosciences is established under the aegis of National Biopharma Mission (NBM) and BIRAC to support medical device Eco system in India.
Like soil (Mrida in Sanskrit) MRIDA is expected to nurture the growth of medical device Industries in India and support the govt’s initiative to create an Atmanirbhar Bharat with reference to the medical device manufacturing segment.
This is the first of its kind dedicated medical devices testing facility in private sector in India complying with various national / international quality systems such as OECD GLP, ISO, AAALAC, CDSCO and NABL. Using large animal models like Pigs, Dogs, Sheep, etc.
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 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...
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 devices
- 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
SERVICESSTAFF TRAINING WORKSHOPS
Staff assisted wet bench hands on education and teaching workshops covering the following areas.
- Ischemia stroke
- Percutaneous Coronary Intervention (PCI) training
- Arrhythmia mapping system learning center for electro-physiological corrections of arrhythmia
- Electroporation training workshops for electrophysiological corrections
- Endoscopic training
- Heart lung surgical set up
- RDN
DBT / BIRAC / NBM GRANTEES
To support the Athma Nirbhar Bharath initiative of the Government of India, Medical Research Institute for Device Assessment (MRIDA) will be offering all grantees and Govt funded institution, all their services at a discounted / competitive rate.
The extent of discounts offered will vary from case to case basis and will depend on the type of services availed. You may review our service range or contact our team for further details in the form provided for.
Additionally, we have a dedicated team of experts in our panel who are engaged with mentoring /advising / preparation of project proposals to various funding agencies like Department of Biotechnology (DBT), Department of Science and Technology (DST), NBM, BIRAC etc. This will include all the pre-clinical support services. We can also partner with you to support your research progress so that you can realise your ambitions.
CONTACT USQuotation Request
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.
