Mrs. Renu-Singh M. Mokashi
Dr. Mrs. Urmila M. Aswar
Dr. Vijay Kanuru
Mr. Sandip N. Kulkarni
BE (Mechanical), MBA-MM
Professional Experience:
Qualified MDD, MDR, MDSAP assessor with working experience of 22 years,
Technical Advisor for laboratory management for Medical devices include General safety, EMC, Microbiology and biocompatibility including the toxicological research.
Qualified GHG quantification verifier as per ISO 14064
Worked for Global technology Centre, Pune (India) , Astute Labs Pvt Ltd, Pune (India) , Safetek Laboratory, Pune (India) , ICL Certifications Ltd, Nasan Medicals , R&D TECH INC, S.H.Pitkar Orthotools Pvt. Ltd etc and different EU Notified bodies.
Working Experience on European Directives and Regulations for medical and non medical products.
Working Experience of identifying and interpretation of the product, process and system standards and achieve the compliances
Has worked in Design, Manufacturing, Inspection and Testing, Vigilance, PMS processes, UDI, Eudamed/FURLS database updation for manufacturers of Implants, Electro-medical devices. Measurement system analysis, Process Validations and qualifications, Stability and shelf-life controls and Studies.
Worked for the Technical files compilation, Biological evaluation, clinical evaluation, Software development life cycle implementation.
Worked with APTRF as a scientific advisor, involved in Delivering the credible presentations on scientific matters to technical audiences, individually or in groups, either reactively or proactively (to disseminate scientific data best aligned with business needs). Produced and updated scientific presentations for assigned research projects as appropriate.