Medical Devices Testing

Medical Devices industry is always in demand with global acceptance increasing day by day results in facing new challenges to provide quality products to the customers require more focus on clinical trials and testing facilities with global standards and as per country specific requirements.

We offer one stop solution for Medical Devices with our strategic partners, having herbal testing lab facilities in India, accredited by National Accreditation Board for testing and Calibration Laboratories (NABL) as per ISO/EC 17025:2005 standards and in compliance with Schedule M III of Drugs and Cosmetics act and Rules

We are Customer-centric service provider. We provide customizable testing solutions of clients’ requirements in Line with Advanced Technology. Clients’ goals become our goals.

We provide services with global compliance expertise. We act as a trusted advisor, helping you navigate the ever-changing compliance landscape with cost effective, speedy results turn-around time and testing accuracy.

Our profile for Medical Devices testing includes

• Determination of bio-burden testing before sterilization
• Sterility testing as per country specific standards like USP, EP etc.
• Biological indicators
• Method development and validation
• Toxicity /Cytotoxicity studies
• Polymer identification
• Container Closure Permeation
• Sealing integrity/ expiration dating studies test for packaging materials
• Bacterial Endotoxin testing
• Ethylene oxide Residual testing according to EN ISO 10993-7:2008
• Environmental monitoring of production zones
• Particulate analysis (Viable and nonviable)
• RODAC and swab analysis of surfaces
• Dye and microbial ingress studies
• Test for Extractable/leachable substances according to EN ISO 10993,173
• Leaching of heavy metals and impurities
• Stability testing
• Identification and purity testing of raw materials
• Environmental monitoring of manufacturing facilities
• Organic residues testing
• Testing for compliance to various IS and ISO standards
• Material Characterization
• Physical Testing
• Elemental Metals testing

Our services includes medical device software testing as per guidelines contained in ISO 13485:2003, Quality Management Systems, and ISO 14971:2007, application of Risk Management to Medical Devices etc. and help to develop your organization with all of the necessary tools for medical device software compliance including

• Software Validation and Testing
• Policies & Procedural Controls
• Quality Agreements
• Predicate Device Research