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Dr. S. S. Murugan
Managing Director
GLR Laboratories Pvt. Ltd.
Chennai

Dr. Murugan is a UK and EU Registered Toxicologist with more than 20 years experience in industry. Dr. Murugan obtained his Bachelors, Masters as well as Doctoral degree in Toxicology from University of Madras and MGR Medical University. He has worked with major contract research organizations (CRO) in India - Head of Genetic Toxicology at IIBAT, Toxicology and Quality Assurance Manager at SGS and Scientific Director at RCC India. He has extensive operational and quality assurance experiences. He has been instrumental in obtained GLP certification and has turned around the business at 2 Indian CROs. He has successfully faced several GLP, ISO17025 and FDA audits. Additionally, he has faced several national and international client audits. He was also a member of CPCSEA guidelines committee, which over sees the animal experimentation in India.


GLR’s approach and strategy on biocompatibility testing of medical devices.

Dr. S S Murugan, Toxicologist and Managing Director, GLR laboratories Pvt Ltd

 

Biocompatibility testing of medical devices presents ongoing challenges due to the constantly evolving guidelines. The complex nature of these devices makes it difficult to determine which parts should be tested individually versus as a whole unit. Additionally, careful planning is required to develop strategies for testing multiple components within the same device. It is important to note that the testing approach for medical devices differs significantly from that of agrochemicals and pharmaceuticals. Factors such as device morphology, incorporated materials, extraction conditions, and unique challenges must be thoroughly considered when designing the testing methodology.

 

The culmination of the biocompatibility testing process is the creation of the Biological Evaluation Report (BER), which adheres to GLR's approach to meet the BER requirements. Throughout the preparation of the BER, we have encountered numerous deficiencies in biocompatibility reports generated by others, as they often deviate from the BER requirements.

GLR diligently addresses each challenge and ensures that no critical parameters are overlooked during the study design phase. During the execution of the study, these critical factors are meticulously measured and monitored to ensure comprehensive and accurate results.

 

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