
Quality Assurance And Regulatory Affairs Incharge
Gokul Kv
Scientific Writing
About me
Quality Assurance and Regulatory professional with an M.Sc. in Biochemistry and experience in medical devices like PMMA based Bone cement, Surgical Implants & Surgical disposables. Expertise in ISO 13485, ISO 9001, CAPA, audits, validation, EtO sterilization, and documentation. I can help students with life science subjects, QA/QC concepts, medical device regulations, resume building, and career guidance.
Interests: My research interests focus on medical device quality systems, ISO 13485 compliance, EtO sterilization, validation studies, cleanroom and contamination control, CAPA, risk management, and regulatory documentation. I am also interested in biochemistry, life sciences, and improving quality and safety in healthcare products.
Skills
My Services
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