Zamir Bar-David
35+ year RA/QA expert & ex-Notified Body Auditor specializing in global submissions (FDA, EU MDR, MDSAP) & QMS for...
Zamir Bar-David is a seasoned regulatory and quality consultant with 35 years of experience in the medical device and pharmaceutical industries. Holding a Master's in Business Operations and a B.S. in Engineering, he leverages his background as a former Lead Auditor for Notified Bodies (Intertek, TUV Rhineland) to provide expert guidance. Zamir specializes in global product registrations across 60 countries, with deep expertise in US FDA submissions (510k), EU MDR/IVDR technical documentation, MDSAP, and QMS development (ISO 13485). His mission is to support start-up, small, and large medical device companies in building robust regulatory infrastructures, navigating compliance challenges, and expanding into global markets.
About
Zamir Bar-David is a seasoned regulatory and quality consultant with 35 years of experience in the medical device and pharmaceutical industries. Holding a Master's in Business Operations and a B.S. in Engineering, he leverages his background as a former Lead Auditor for Notified Bodies (Intertek, TUV Rhineland) to provide expert guidance. Zamir specializes in global product registrations across 60 countries, with deep expertise in US FDA submissions (510k), EU MDR/IVDR technical documentation, MDSAP, and QMS development (ISO 13485). His mission is to support start-up, small, and large medical device companies in building robust regulatory infrastructures, navigating compliance challenges, and expanding into global markets.
Additional information
### **Additional information**
- **Type:** independent
- **Company:** Regulations Now
- **Years of experience:** 35
- **Ex-Notified Body:** Yes
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA, APAC, LATAM, MEA
- **Client types:** startup, sme, large_medtech
- **Location:** United States (NJ)
- **Availability:** available_now
- **Certifications:** EU MDR Training and Certification, Lead Auditor Certification, Assessor of Quality System, Health Canada MDR/CMDCAS Canadian Medical Device Conformity Assessment System, MDSAP Scheme Qualification
---
### **Cruxi analysis**
- **Strength summary:** Zamir Bar-David offers medtech companies an exceptional strategic advantage, built upon 35 years of experience and a rare dual perspective as both a global consultant and a former Lead Auditor for top Notified Bodies (Intertek, TUV Rhineland). This 'insider's view' is invaluable for building robust, audit-proof Quality Management Systems (ISO 13485, MDSAP) and de-risking regulatory submissions. His proven track record of securing product registrations in over 60 countries, combined with deep expertise in US FDA 510(k) submissions and EU MDR technical documentation, demonstrates a mastery of the most critical global markets. Zamir's engineering and business background further empowers him to translate complex regulatory requirements into actionable commercial strategies, making him a comprehensive partner for market success.
- **Unique value:** Zamir Bar-David's key differentiator is his direct experience as a former Notified Body Lead Auditor, providing clients with an unparalleled understanding of how regulators and auditors think. This unique insight allows companies to proactively build submissions and quality systems that are designed to withstand scrutiny, significantly streamlining the path to market clearance. This 'view from the other side of the table' transforms regulatory compliance from a reactive challenge into a proactive strategic asset.
- **Ideal projects:** The ideal project for Zamir is with a startup or SME medtech company navigating the complexities of its first 510(k) submission, transitioning to EU MDR, or planning a multi-market global launch. Companies with devices in the Orthopedic, Cardiovascular, IVD, and Software as a Medical Device (SaMD) sectors will find his specialized expertise particularly potent. He is perfectly suited for engagements that require building a regulatory infrastructure from the ground up, remediating a QMS to meet ISO 13485 and MDSAP standards, or authoring a complete technical file for a complex device. Larger organizations will also benefit significantly from his expertise in conducting mock audits to ensure they are inspection-ready for FDA or Notified Body assessments.
- **Last analyzed:** Sun Jan 25 2026 22:29:46 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, qms, international, clinical-trials
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** orthopedic, software-samd, ivd, clinical-chemistry, general-hospital, anesthesiology, cardiovascular
- **Device panels:** orthopedic, general_surgery, anesthesiology, ivd, cardiovascular, other
- **Regulatory pathways:** 510k, post_market
---
- **Type:** independent
- **Company:** Regulations Now
- **Years of experience:** 35
- **Ex-Notified Body:** Yes
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, CA, APAC, LATAM, MEA
- **Client types:** startup, sme, large_medtech
- **Location:** United States (NJ)
- **Availability:** available_now
- **Certifications:** EU MDR Training and Certification, Lead Auditor Certification, Assessor of Quality System, Health Canada MDR/CMDCAS Canadian Medical Device Conformity Assessment System, MDSAP Scheme Qualification
---
### **Cruxi analysis**
- **Strength summary:** Zamir Bar-David offers medtech companies an exceptional strategic advantage, built upon 35 years of experience and a rare dual perspective as both a global consultant and a former Lead Auditor for top Notified Bodies (Intertek, TUV Rhineland). This 'insider's view' is invaluable for building robust, audit-proof Quality Management Systems (ISO 13485, MDSAP) and de-risking regulatory submissions. His proven track record of securing product registrations in over 60 countries, combined with deep expertise in US FDA 510(k) submissions and EU MDR technical documentation, demonstrates a mastery of the most critical global markets. Zamir's engineering and business background further empowers him to translate complex regulatory requirements into actionable commercial strategies, making him a comprehensive partner for market success.
- **Unique value:** Zamir Bar-David's key differentiator is his direct experience as a former Notified Body Lead Auditor, providing clients with an unparalleled understanding of how regulators and auditors think. This unique insight allows companies to proactively build submissions and quality systems that are designed to withstand scrutiny, significantly streamlining the path to market clearance. This 'view from the other side of the table' transforms regulatory compliance from a reactive challenge into a proactive strategic asset.
- **Ideal projects:** The ideal project for Zamir is with a startup or SME medtech company navigating the complexities of its first 510(k) submission, transitioning to EU MDR, or planning a multi-market global launch. Companies with devices in the Orthopedic, Cardiovascular, IVD, and Software as a Medical Device (SaMD) sectors will find his specialized expertise particularly potent. He is perfectly suited for engagements that require building a regulatory infrastructure from the ground up, remediating a QMS to meet ISO 13485 and MDSAP standards, or authoring a complete technical file for a complex device. Larger organizations will also benefit significantly from his expertise in conducting mock audits to ensure they are inspection-ready for FDA or Notified Body assessments.
- **Last analyzed:** Sun Jan 25 2026 22:29:46 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, qms, international, clinical-trials
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** orthopedic, software-samd, ivd, clinical-chemistry, general-hospital, anesthesiology, cardiovascular
- **Device panels:** orthopedic, general_surgery, anesthesiology, ivd, cardiovascular, other
- **Regulatory pathways:** 510k, post_market
---
Key Highlights
- Zamir Bar-David offers medtech companies an exceptional strategic advantage, built upon 35 years of experience and a rare dual perspective as both a global consultant and a former Lead Auditor for top Notified Bodies (Intertek, TUV Rhineland). This 'insider's view' is invaluable for building robust, audit-proof Quality Management Systems (ISO 13485, MDSAP) and de-risking regulatory submissions. His proven track record of securing product registrations in over 60 countries, combined with deep exp
- Zamir Bar-David's key differentiator is his direct experience as a former Notified Body Lead Auditor, providing clients with an unparalleled understanding of how regulators and auditors think. This unique insight allows companies to proactively build submissions and quality systems that are designed to withstand scrutiny, significantly streamlining the path to market clearance. This 'view from the other side of the table' transforms regulatory compliance from a reactive challenge into a proactiv
Certifications & Trust Signals
- 35 years experience
- Ex-Notified Body
Buyer Snapshot
Best for
- The ideal project for Zamir is with a startup or SME medtech company navigating the complexities of its first 510(k) submission, transitioning to EU MDR, or planning a multi-market global launch. Companies with devices in the Orthopedic, Cardiovascular, IVD, and Software as a Medical Device (SaMD) sectors will find his specialized expertise particularly potent. He is perfectly suited for engagemen
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) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), Special 510(k)
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
35
Ex FDA:
No
Ex Notified Body:
Yes
Ex Big Medtech:
Yes
Device Panels:
orthopedic, general_surgery, anesthesiology, ivd, cardiovascular, other
Technology Types:
samd, implantable, ivd_test
Accepting New Clients:
Yes
