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.
About
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.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 0.9
- **Ex-Big MedTech:** Yes
- **Regions served:** US, APAC
- **Client types:** large_medtech
- **Location:** Other
- **Availability:** available_now
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### **Cruxi analysis**
- **Strength summary:** With nearly a year of focused experience at a major global medtech company, this consultant offers highly relevant and current expertise in post-market surveillance. They possess direct, hands-on skills in the complete complaint handling lifecycle for Class II and Class III devices, including FDA reportability assessments, CIR preparation, and submissions compliant with 21 CFR 820.198. Their technical proficiency is enhanced by a background in cardiovascular and general surgery devices. What truly elevates their value is their foundational education as a Bachelor of Science in Nursing, providing a critical clinical perspective to regulatory analysis that ensures a deep understanding of patient safety and adverse events.
- **Unique value:** This consultant’s unique value proposition is the powerful combination of a clinical nursing background with specialized post-market regulatory experience in a large medtech setting. This duality provides medtech companies with a rare, ground-level understanding of adverse events, ensuring that complaint investigations and FDA reporting are not only compliant but also clinically astute and patient-focused.
- **Ideal projects:** The ideal project for this consultant involves a large or mid-sized medtech company seeking to enhance its post-market surveillance operations. They are perfectly suited to augment an existing quality or regulatory team by managing complaint handling workflows, conducting reportability assessments, and drafting adverse event reports, especially for Class II or Class III cardiovascular or general surgery products. Companies preparing for an FDA audit or looking to improve the quality and efficiency of their complaint investigations would benefit immensely from their detail-oriented approach. Engage this professional to bring a clinically-informed, process-driven expertise to ensure robust compliance and audit readiness.
- **Last analyzed:** Sun Jan 04 2026 01:29:37 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** qms
- **Device classes:** class-iii, class-ii
- **Specialties:** general-hospital
- **Device panels:** anesthesiology, general_surgery, cardiovascular, other
- **Regulatory pathways:** post_market, 510k
---
- **Type:** independent
- **Years of experience:** 0.9
- **Ex-Big MedTech:** Yes
- **Regions served:** US, APAC
- **Client types:** large_medtech
- **Location:** Other
- **Availability:** available_now
---
### **Cruxi analysis**
- **Strength summary:** With nearly a year of focused experience at a major global medtech company, this consultant offers highly relevant and current expertise in post-market surveillance. They possess direct, hands-on skills in the complete complaint handling lifecycle for Class II and Class III devices, including FDA reportability assessments, CIR preparation, and submissions compliant with 21 CFR 820.198. Their technical proficiency is enhanced by a background in cardiovascular and general surgery devices. What truly elevates their value is their foundational education as a Bachelor of Science in Nursing, providing a critical clinical perspective to regulatory analysis that ensures a deep understanding of patient safety and adverse events.
- **Unique value:** This consultant’s unique value proposition is the powerful combination of a clinical nursing background with specialized post-market regulatory experience in a large medtech setting. This duality provides medtech companies with a rare, ground-level understanding of adverse events, ensuring that complaint investigations and FDA reporting are not only compliant but also clinically astute and patient-focused.
- **Ideal projects:** The ideal project for this consultant involves a large or mid-sized medtech company seeking to enhance its post-market surveillance operations. They are perfectly suited to augment an existing quality or regulatory team by managing complaint handling workflows, conducting reportability assessments, and drafting adverse event reports, especially for Class II or Class III cardiovascular or general surgery products. Companies preparing for an FDA audit or looking to improve the quality and efficiency of their complaint investigations would benefit immensely from their detail-oriented approach. Engage this professional to bring a clinically-informed, process-driven expertise to ensure robust compliance and audit readiness.
- **Last analyzed:** Sun Jan 04 2026 01:29:37 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** qms
- **Device classes:** class-iii, class-ii
- **Specialties:** general-hospital
- **Device panels:** anesthesiology, general_surgery, cardiovascular, other
- **Regulatory pathways:** post_market, 510k
---
Key Highlights
- With nearly a year of focused experience at a major global medtech company, this consultant offers highly relevant and current expertise in post-market surveillance. They possess direct, hands-on skills in the complete complaint handling lifecycle for Class II and Class III devices, including FDA reportability assessments, CIR preparation, and submissions compliant with 21 CFR 820.198. Their technical proficiency is enhanced by a background in cardiovascular and general surgery devices. What tru
- This consultant’s unique value proposition is the powerful combination of a clinical nursing background with specialized post-market regulatory experience in a large medtech setting. This duality provides medtech companies with a rare, ground-level understanding of adverse events, ensuring that complaint investigations and FDA reporting are not only compliant but also clinically astute and patient-focused.
Certifications & Trust Signals
- 0.9 years experience
Buyer Snapshot
Best for
- The ideal project for this consultant involves a large or mid-sized medtech company seeking to enhance its post-market surveillance operations. They are perfectly suited to augment an existing quality or regulatory team by managing complaint handling workflows, conducting reportability assessments, and drafting adverse event reports, especially for Class II or Class III cardiovascular or general s
HQ:
Other
Languages:
English, Tamil
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
