Hiren Patel
Expert QA/RA Director | MedTech Product Launch | FDA, EU-MDR, MDSAP | QMS & Validation Specialist
Highly accomplished QA/RA professional with over 12 years of extensive experience in the medical device industry, specializing in design, quality assurance, and regulatory support from concept to commercialization. Proven track record of successful product launches, including COVID diagnostics, orthopedic implants, catheters, and SaMD. Expertise in navigating complex regulatory pathways such as FDA QSR, EU-MDR, and MDSAP, with demonstrated success in audit readiness and remediation for startups and established companies. Adept at developing and implementing robust Quality Management Systems, risk management, validation strategies, and managing cross-functional teams to ensure compliance and drive project success.
About
Highly accomplished QA/RA professional with over 12 years of extensive experience in the medical device industry, specializing in design, quality assurance, and regulatory support from concept to commercialization. Proven track record of successful product launches, including COVID diagnostics, orthopedic implants, catheters, and SaMD. Expertise in navigating complex regulatory pathways such as FDA QSR, EU-MDR, and MDSAP, with demonstrated success in audit readiness and remediation for startups and established companies. Adept at developing and implementing robust Quality Management Systems, risk management, validation strategies, and managing cross-functional teams to ensure compliance and drive project success.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 12
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU
- **Client types:** startup, sme
- **Location:** United States (Florida)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** With 12 years of extensive experience, this QA/RA Director is a formidable asset for medtech companies seeking robust regulatory and quality assurance support. Their deep expertise spans the entire product lifecycle, from initial concept through commercialization, with a proven track record of successfully launching diverse devices including critical COVID diagnostics, orthopedic implants, and SaMD. Hiren Patel demonstrates exceptional proficiency in navigating complex global regulatory landscapes, specifically the US FDA QSR, EU-MDR, and MDSAP, making them invaluable for companies targeting both US and EU markets. Their technical competencies in QMS implementation, risk management (ISO 14971), and validation strategies (IQ/TMV/OQ/PQ/PPQ) ensure a strong foundation for compliance and product success, setting them apart as a comprehensive solution provider.
- **Unique value:** Hiren Patel offers a unique blend of deep technical understanding and practical, end-to-end regulatory execution, proven by successful product launches across diverse device categories. Their comprehensive expertise in QMS, risk management, validation, and navigating intricate global regulatory frameworks like FDA, EU-MDR, and MDSAP makes them a rare find for medtech companies aiming for seamless market entry and sustained compliance.
- **Ideal projects:** This consultant is ideally suited for startups and SMEs in the medtech sector, particularly those developing Class I, II, or III devices within the IVD, orthopedic, or SaMD/wearable digital space. They excel in projects requiring robust QMS setup, comprehensive regulatory pathway assessment (especially 510(k) and post-market strategies), and expert support for FDA mock audits or remediation efforts. Companies embarking on their first major submission, facing complex international regulatory hurdles (US & EU), or requiring seasoned leadership to ensure audit readiness and drive project success from design to market launch would benefit immensely from their engagement. They are available now to tackle these critical needs.
- **Confidence score:** 65/100
- **Last analyzed:** Mon Jan 05 2026 15:36:36 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** ivd, orthopedic, software-samd, cardiovascular, clinical-chemistry, hematology
- **Device panels:** ivd, orthopedic, wearable_digital, other
- **Regulatory pathways:** 510k, post_market
- **Type:** independent
- **Years of experience:** 12
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU
- **Client types:** startup, sme
- **Location:** United States (Florida)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** With 12 years of extensive experience, this QA/RA Director is a formidable asset for medtech companies seeking robust regulatory and quality assurance support. Their deep expertise spans the entire product lifecycle, from initial concept through commercialization, with a proven track record of successfully launching diverse devices including critical COVID diagnostics, orthopedic implants, and SaMD. Hiren Patel demonstrates exceptional proficiency in navigating complex global regulatory landscapes, specifically the US FDA QSR, EU-MDR, and MDSAP, making them invaluable for companies targeting both US and EU markets. Their technical competencies in QMS implementation, risk management (ISO 14971), and validation strategies (IQ/TMV/OQ/PQ/PPQ) ensure a strong foundation for compliance and product success, setting them apart as a comprehensive solution provider.
- **Unique value:** Hiren Patel offers a unique blend of deep technical understanding and practical, end-to-end regulatory execution, proven by successful product launches across diverse device categories. Their comprehensive expertise in QMS, risk management, validation, and navigating intricate global regulatory frameworks like FDA, EU-MDR, and MDSAP makes them a rare find for medtech companies aiming for seamless market entry and sustained compliance.
- **Ideal projects:** This consultant is ideally suited for startups and SMEs in the medtech sector, particularly those developing Class I, II, or III devices within the IVD, orthopedic, or SaMD/wearable digital space. They excel in projects requiring robust QMS setup, comprehensive regulatory pathway assessment (especially 510(k) and post-market strategies), and expert support for FDA mock audits or remediation efforts. Companies embarking on their first major submission, facing complex international regulatory hurdles (US & EU), or requiring seasoned leadership to ensure audit readiness and drive project success from design to market launch would benefit immensely from their engagement. They are available now to tackle these critical needs.
- **Confidence score:** 65/100
- **Last analyzed:** Mon Jan 05 2026 15:36:36 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** ivd, orthopedic, software-samd, cardiovascular, clinical-chemistry, hematology
- **Device panels:** ivd, orthopedic, wearable_digital, other
- **Regulatory pathways:** 510k, post_market
Key Highlights
- With 12 years of extensive experience, this QA/RA Director is a formidable asset for medtech companies seeking robust regulatory and quality assurance support. Their deep expertise spans the entire product lifecycle, from initial concept through commercialization, with a proven track record of successfully launching diverse devices including critical COVID diagnostics, orthopedic implants, and SaMD. Hiren Patel demonstrates exceptional proficiency in navigating complex global regulatory landscap
- Hiren Patel offers a unique blend of deep technical understanding and practical, end-to-end regulatory execution, proven by successful product launches across diverse device categories. Their comprehensive expertise in QMS, risk management, validation, and navigating intricate global regulatory frameworks like FDA, EU-MDR, and MDSAP makes them a rare find for medtech companies aiming for seamless market entry and sustained compliance.
Certifications & Trust Signals
- 12 years experience
Buyer Snapshot
Best for
- This consultant is ideally suited for startups and SMEs in the medtech sector, particularly those developing Class I, II, or III devices within the IVD, orthopedic, or SaMD/wearable digital space. They excel in projects requiring robust QMS setup, comprehensive regulatory pathway assessment (especially 510(k) and post-market strategies), and expert support for FDA mock audits or remediation effort
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
12
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
ivd, orthopedic, wearable_digital, other
Technology Types:
samd, wearable_patch, ivd_test
Accepting New Clients:
No
