Abu Usama Ansari

• Supported the R&D team in developing and implementing new strategies for reduced deliverable time.
• Assisted and authored technical documentation for US FDA and EU MDR regulatory submissions.
• Conducted Technical document Gap assessment for class I and class II medical devices as per USFDA QMSR
and 21CFR820.30: User requirements, Product requirements - Design verification and validation Plan protocol,
reports - Test method, Packaging Requirements (ISO11607), Manufacturing Symbols (ISO 15223).
• Ensured compliance with regulatory standard ISO 13485 guidelines, ISO 60601-1 and product specific standards.
• Assisted in developing remediation strategies and preparing technical documentation to ensure compliance with
state-of-the-art standards and regulatory requirements in the US and EU region.
• Drafted Design Input, Design Verification documents, Design Validation documents, Test Protocols and Technical
memo.
• Collaborated in cross-functional teams to create product risk management files, including risk management plans,
DFMEA, and risk management reports.
• Conducted advanced statistical analysis of testing data using Minitab software, enabling data-driven decision-
making and ensuring compliance with regulatory standards for product development and submissions.

• Worked with the Biomedical Engineering team to ensure the smooth functioning of all machines and equipment.
• Attended breakdown calls and maintained records ofthe same.
• Collaborated with service engineers to deliver success in properly functioning machines.
• Conduct device calibration, servicing, and maintenance for diagnosing hardware malfunctions.