Amey Kawale
Expert QMS & ISO 14971 Risk Management Pro | EU MDR, SaMD, IVD Compliance | 10+ Yrs MedTech Experience
A highly accomplished Quality Management Systems (QMS) and ISO 14971 Risk Management professional with over 10 years of experience in the medical device industry. Specializing in EU MDR gap assessment, technical file remediation, and regulatory compliance for Class II/III medical devices, SaMD, and IVDs. Proven ability to lead global teams and harmonize complex QMS programs, with deep expertise in risk management processes including Risk Management Plans, DFMEA, UFMEA, PFMEA, Benefit-Risk assessment, Health Hazard Evaluations, and Risk Management Reports. Adept at driving design controls, technical documentation, and inspection-ready files in fast-paced, regulated environments. Successfully managed FDA QMSR projects, ensuring timely compliance.
About
A highly accomplished Quality Management Systems (QMS) and ISO 14971 Risk Management professional with over 10 years of experience in the medical device industry. Specializing in EU MDR gap assessment, technical file remediation, and regulatory compliance for Class II/III medical devices, SaMD, and IVDs. Proven ability to lead global teams and harmonize complex QMS programs, with deep expertise in risk management processes including Risk Management Plans, DFMEA, UFMEA, PFMEA, Benefit-Risk assessment, Health Hazard Evaluations, and Risk Management Reports. Adept at driving design controls, technical documentation, and inspection-ready files in fast-paced, regulated environments. Successfully managed FDA QMSR projects, ensuring timely compliance.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 11
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU
- **Client types:** sme, large_medtech
- **Location:** United States (CA)
- **Availability:** available_now
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### **Cruxi analysis**
- **Strength summary:** With over 11 years of experience in the medical device industry, this consultant specializes in EU MDR gap assessment, technical file remediation, and regulatory compliance for Class II/III medical devices, SaMD, and IVDs. Holding a Master of Science in Mechanical Engineering and a Bachelor of Technology and Master of Technology in Mechanical Engineering, this consultant possesses a robust academic foundation and deep expertise in risk management processes including Risk Management Plans, DFMEA, UFMEA, PFMEA, Benefit-Risk assessment, Health Hazard Evaluations, and Risk Management Reports. They have successfully managed FDA QMSR projects, ensuring timely compliance, and have a proven track record of managing complex Quality Management Systems (QMS) and ISO 14971 Risk Management programs. This consultant's regulatory expertise depth, FDA experience, and technical competencies make them uniquely valuable for medtech companies.
- **Unique value:** This consultant stands out for their unique combination of deep regulatory expertise, extensive FDA experience, and technical skills in risk management processes and SaMD applications. Their ability to successfully manage complex QMS and ISO 14971 Risk Management programs, alongside their experience in FDA QMSR project management, makes them a valuable asset to medtech companies seeking to ensure timely compliance and inspection readiness.
- **Ideal projects:** The perfect medtech client for this consultant is a large medtech company or a well-established SME that is in need of regulatory compliance for Class II/III medical devices, SaMD, or IVDs. They excel in projects related to EU MDR remediation, technical file remediation, and 510(k) submissions. With their expertise in risk management processes and FDA QMSR project management, this consultant can effectively guide companies through complex regulatory pathways and ensure inspection readiness. They are ideal for projects involving complex devices, international expansion, or first-time submissions.
- **Last analyzed:** Tue Dec 23 2025 00:13:16 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** qms, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** ivd, software-samd, other
- **Device panels:** ivd, wearable_digital, other
- **Regulatory pathways:** 510k, q_sub, post_market
---
- **Type:** independent
- **Years of experience:** 11
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU
- **Client types:** sme, large_medtech
- **Location:** United States (CA)
- **Availability:** available_now
---
### **Cruxi analysis**
- **Strength summary:** With over 11 years of experience in the medical device industry, this consultant specializes in EU MDR gap assessment, technical file remediation, and regulatory compliance for Class II/III medical devices, SaMD, and IVDs. Holding a Master of Science in Mechanical Engineering and a Bachelor of Technology and Master of Technology in Mechanical Engineering, this consultant possesses a robust academic foundation and deep expertise in risk management processes including Risk Management Plans, DFMEA, UFMEA, PFMEA, Benefit-Risk assessment, Health Hazard Evaluations, and Risk Management Reports. They have successfully managed FDA QMSR projects, ensuring timely compliance, and have a proven track record of managing complex Quality Management Systems (QMS) and ISO 14971 Risk Management programs. This consultant's regulatory expertise depth, FDA experience, and technical competencies make them uniquely valuable for medtech companies.
- **Unique value:** This consultant stands out for their unique combination of deep regulatory expertise, extensive FDA experience, and technical skills in risk management processes and SaMD applications. Their ability to successfully manage complex QMS and ISO 14971 Risk Management programs, alongside their experience in FDA QMSR project management, makes them a valuable asset to medtech companies seeking to ensure timely compliance and inspection readiness.
- **Ideal projects:** The perfect medtech client for this consultant is a large medtech company or a well-established SME that is in need of regulatory compliance for Class II/III medical devices, SaMD, or IVDs. They excel in projects related to EU MDR remediation, technical file remediation, and 510(k) submissions. With their expertise in risk management processes and FDA QMSR project management, this consultant can effectively guide companies through complex regulatory pathways and ensure inspection readiness. They are ideal for projects involving complex devices, international expansion, or first-time submissions.
- **Last analyzed:** Tue Dec 23 2025 00:13:16 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** qms, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** ivd, software-samd, other
- **Device panels:** ivd, wearable_digital, other
- **Regulatory pathways:** 510k, q_sub, post_market
---
Key Highlights
- With over 11 years of experience in the medical device industry, this consultant specializes in EU MDR gap assessment, technical file remediation, and regulatory compliance for Class II/III medical devices, SaMD, and IVDs. Holding a Master of Science in Mechanical Engineering and a Bachelor of Technology and Master of Technology in Mechanical Engineering, this consultant possesses a robust academic foundation and deep expertise in risk management processes including Risk Management Plans, DFMEA,
- This consultant stands out for their unique combination of deep regulatory expertise, extensive FDA experience, and technical skills in risk management processes and SaMD applications. Their ability to successfully manage complex QMS and ISO 14971 Risk Management programs, alongside their experience in FDA QMSR project management, makes them a valuable asset to medtech companies seeking to ensure timely compliance and inspection readiness.
Certifications & Trust Signals
- 11 years experience
Buyer Snapshot
Best for
- The perfect medtech client for this consultant is a large medtech company or a well-established SME that is in need of regulatory compliance for Class II/III medical devices, SaMD, or IVDs. They excel in projects related to EU MDR remediation, technical file remediation, and 510(k) submissions. With their expertise in risk management processes and FDA QMSR project management, this consultant can e
HQ:
United States
Languages:
English
Status:
claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Pre-Sub / Q-Sub
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Years Experience:
11
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
ivd, wearable_digital, other
Technology Types:
samd, ai_ml
Accepting New Clients:
No
