KISHORE P
Medical Device PMS Analyst skilled in Complaint Handling, FDA Reporting, Risk Management (ISO 14971), and QMS (21...
A detail-oriented life science professional specializing in post-market surveillance (PMS) for medical devices. Possesses direct experience in the complete complaint handling lifecycle, from intake and documentation in Salesforce to conducting FDA reportability assessments and executing thorough investigations. Skilled in preparing detailed Complaint Investigation Reports (CIR), writing adverse event summaries, and submitting FDA reports in compliance with regulatory timelines. Proficient in applying QMS principles (21 CFR 820.198) and contributing to risk management activities (ISO 14971), ensuring audit readiness and high-quality data. Eager to leverage analytical skills and a strong patient safety focus to support medtech companies in their post-market compliance and healthcare outcome improvement goals.
HQ:
Other
Languages:
English, Tamil
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment
Device Types Supported:
Medical device
Years Experience:
0
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
anesthesiology, general_surgery, cardiovascular, other
Engagement Models:
hourly
Accepting New Clients:
Yes
