Raghavendra Angara
PhD, PMP, CQE, CSQE, RAC(Devices) - R&D Leader - Medical Device Innovator - 43 Approved Patents - Expert in EU MDR and FDA Regulatory Compliance Implantable Medical Devices, Software as Medical Device
- Role
- Technical Specialist at British Standards Institute (Bsi) at BSI
- Location
- West Chester, PA, US
- LinkedIn followers
- 500 followers
About Raghavendra Angara
I have a robust background in Research and Development with a proven track record in…
Experience
Technical Specialist at British Standards Institute (Bsi)
Apr 2019 — Present
I conduct thorough in-depth Technical Conformity Assessments (100+ regulatory submissions to date) of Medical Devices for Medical Device Regulation (MDR), In Vitro Diagnostic Regulations (IVDR), Active Implantable Medical Devices Directive (AIMDD), and Medical Device Directive (MDD) for a broad range of medical devices including but not limited to Active Implantable Medical Devices, Active Devices, Software as Medical Devices (SaMDs) including those with Artificial Intelligence (AI).Collaborated with teams of 6 to 10 Regulatory experts for each of the Reviews and managed effectively to ensure a seamless outcome to serve patients with critical conditions. Manufacturer\'s Technical Documentation are assessed for Conformity to General Safety and Performance Requirements, and Essential Requirements in all the areas related to• User Needs and Product Requirements, • Risk Management, FMEAs• Verifications and Validations• Usability and Human Factors validations• Information supplied by the Manufacturer (IFUs, Labels, Implant Cards, Marketing material),• Biological Safety, CMR Substances,• Electrical and Electronics Design including EMC,• Software Life Cycle, and Cybersecurity,• Packaging, • Shelf life,• Transit, • Measuring Functions,• Post Market Surveillance (PMS) Plans, PMS Data, Corrective and Preventative Actions,(CAPAs), Field Safety Corrective Actions (FSCAs) Well versed in Standards including 13485, 14971, 62366, 10993, 60601, 14708, 62304, 11607, 11608, 11040, 15223 etc.Submissions I reviewed include initial MDR Applications, Amendments, Renewals, Surveillance Audits, and Change Notifications. I have played crucial role in either recommendation or the refusal of CE, MDR, and UKCA Certifications based on the outcome of the Conformity Assessments. • Communicated effectively with more than 30 leading Medical Device Manufacturers of the world.• Always prioritized to complete the projects within the planned Schedules and allotted Budgets.
Education
University of Nebraska-Lincoln
Master of Science (MS)
2001 — 2004
University of Maryland Baltimore County
PhD
2004 — 2008
JNTU
Bachelor of Technology (B.Tech.)
1997 — 2001
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