Medical Devices and Food supplements

Medical Devices

• Literature reviews to evaluate biological safety / to establish allowable limits for leachables / device components
• Risk assessment of Extractables & Leachables (E&L) to support chemical characterization
• Biological Evaluation Plan (BEP) and Biocompatibility/ Biological safety assessments preparation to comply with ISO 10993:1 / USFDA / EU Medical Device Regulation (MDR) requirements
• Animal testing services requirements evaluation (if needed) as per Medical Devices Classification
• Medical Device Technical Files review services for CE marking process

Vitamins/ Dietary Supplements/ FSSAI regulated Nutraceuticals

• Product safety assessment and authority compliant product labels preparation to comply with local regulations (US FDA, European Food Safety Authority, FSSAI India etc.)
• Color Additives safety assessment