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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. |
