Michael V. Ward
Expert FDA Regulatory & Clinical Consultant | Driving Medtech Innovation from Strategy to Submission.
Highly accomplished and results-driven Clinical & Regulatory Professional with extensive executive leadership experience in the medical device industry. Dr. Ward possesses a profound expertise in navigating complex regulatory pathways, including FDA [IDE/510(k)/PMA], CE Mark, and other international submissions. He excels in developing robust regulatory strategies, managing global clinical trials, and conducting comprehensive biocompatibility and safety assessments. His proven ability to drive successful outcomes, exemplified by achieving Breakthrough Device Designation for multiple companies and resolving critical FDA concerns, makes him an invaluable asset for medtech companies seeking to accelerate product development and market entry with confidence and efficiency.
About
Highly accomplished and results-driven Clinical & Regulatory Professional with extensive executive leadership experience in the medical device industry. Dr. Ward possesses a profound expertise in navigating complex regulatory pathways, including FDA [IDE/510(k)/PMA], CE Mark, and other international submissions. He excels in developing robust regulatory strategies, managing global clinical trials, and conducting comprehensive biocompatibility and safety assessments. His proven ability to drive successful outcomes, exemplified by achieving Breakthrough Device Designation for multiple companies and resolving critical FDA concerns, makes him an invaluable asset for medtech companies seeking to accelerate product development and market entry with confidence and efficiency.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 16
- **510(k)s submitted (self-reported):** 50
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, APAC
- **Client types:** sme, large_medtech, startup
- **Location:** United States (CA)
- **Availability:** available_now
- **Certifications:** MDR Certificate of Training, OHRP Certification of Training on Good Clinical Practice
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### **Cruxi analysis**
- **Strength summary:** With 16 years of executive leadership experience in the medical device industry, Michael V. Ward is an exceptionally valuable FDA regulatory consultant. His profound expertise spans complex regulatory pathways, including IDE, 510(k), and PMA submissions, alongside CE Mark and international requirements, demonstrating a comprehensive understanding of global market access. He excels in developing robust regulatory strategies, managing global clinical trials, and conducting critical safety assessments, evidenced by successfully achieving Breakthrough Device Designation for multiple companies and resolving challenging FDA concerns. His strong scientific foundation, including a background in pharmacology and immunology, coupled with extensive experience in cardiovascular, neurology, and IVD devices, allows him to provide insightful and actionable guidance for medtech professionals seeking to accelerate product development and market entry with confidence and efficiency.
- **Unique value:** Michael V. Ward uniquely distinguishes himself through a powerful combination of deep scientific expertise (DVM, MSc, Post-doc in immunology), extensive executive-level regulatory leadership, and a proven track record of achieving critical regulatory milestones, including Breakthrough Device Designation and resolving complex FDA issues. This blend of scientific acumen and hands-on submission success makes him an invaluable strategic partner for medtech innovators.
- **Ideal projects:** This consultant is ideally suited for medtech companies developing innovative Class II and Class III devices, particularly in the cardiovascular, neurology, radiology, and IVD sectors. They are an excellent fit for companies navigating complex regulatory pathways such as PMA, De Novo, or seeking Breakthrough Device Designation. Startups, SMEs, and large medtech firms looking to establish robust QMS, conduct global clinical trials, or require expert support for challenging FDA deficiency resolutions will find significant value. Engaging this consultant early in the product development lifecycle for pathway assessment and strategy development is highly recommended for optimal outcomes.
- **Last analyzed:** Sat Dec 20 2025 01:19:25 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** pma, clinical-trials, international, 510k-traditional, 510k-special, de_novo
- **Device classes:** class-ii, class-iii
- **Specialties:** cardiovascular, neurology, radiology, ivd, pathology, other, regulatory strategy, risk management, clinical trials, preclinical testing, clinical evaluation
- **Device panels:** cardiovascular, neurology, radiology, ivd, other
- **Regulatory pathways:** 510k, pma, ide, hde, breakthrough_devices
---
- **Type:** independent
- **Years of experience:** 16
- **510(k)s submitted (self-reported):** 50
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, APAC
- **Client types:** sme, large_medtech, startup
- **Location:** United States (CA)
- **Availability:** available_now
- **Certifications:** MDR Certificate of Training, OHRP Certification of Training on Good Clinical Practice
---
### **Cruxi analysis**
- **Strength summary:** With 16 years of executive leadership experience in the medical device industry, Michael V. Ward is an exceptionally valuable FDA regulatory consultant. His profound expertise spans complex regulatory pathways, including IDE, 510(k), and PMA submissions, alongside CE Mark and international requirements, demonstrating a comprehensive understanding of global market access. He excels in developing robust regulatory strategies, managing global clinical trials, and conducting critical safety assessments, evidenced by successfully achieving Breakthrough Device Designation for multiple companies and resolving challenging FDA concerns. His strong scientific foundation, including a background in pharmacology and immunology, coupled with extensive experience in cardiovascular, neurology, and IVD devices, allows him to provide insightful and actionable guidance for medtech professionals seeking to accelerate product development and market entry with confidence and efficiency.
- **Unique value:** Michael V. Ward uniquely distinguishes himself through a powerful combination of deep scientific expertise (DVM, MSc, Post-doc in immunology), extensive executive-level regulatory leadership, and a proven track record of achieving critical regulatory milestones, including Breakthrough Device Designation and resolving complex FDA issues. This blend of scientific acumen and hands-on submission success makes him an invaluable strategic partner for medtech innovators.
- **Ideal projects:** This consultant is ideally suited for medtech companies developing innovative Class II and Class III devices, particularly in the cardiovascular, neurology, radiology, and IVD sectors. They are an excellent fit for companies navigating complex regulatory pathways such as PMA, De Novo, or seeking Breakthrough Device Designation. Startups, SMEs, and large medtech firms looking to establish robust QMS, conduct global clinical trials, or require expert support for challenging FDA deficiency resolutions will find significant value. Engaging this consultant early in the product development lifecycle for pathway assessment and strategy development is highly recommended for optimal outcomes.
- **Last analyzed:** Sat Dec 20 2025 01:19:25 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** pma, clinical-trials, international, 510k-traditional, 510k-special, de_novo
- **Device classes:** class-ii, class-iii
- **Specialties:** cardiovascular, neurology, radiology, ivd, pathology, other, regulatory strategy, risk management, clinical trials, preclinical testing, clinical evaluation
- **Device panels:** cardiovascular, neurology, radiology, ivd, other
- **Regulatory pathways:** 510k, pma, ide, hde, breakthrough_devices
---
Key Highlights
- With 16 years of executive leadership experience in the medical device industry, Michael V. Ward is an exceptionally valuable FDA regulatory consultant. His profound expertise spans complex regulatory pathways, including IDE, 510(k), and PMA submissions, alongside CE Mark and international requirements, demonstrating a comprehensive understanding of global market access. He excels in developing robust regulatory strategies, managing global clinical trials, and conducting critical safety assessme
- Michael V. Ward uniquely distinguishes himself through a powerful combination of deep scientific expertise (DVM, MSc, Post-doc in immunology), extensive executive-level regulatory leadership, and a proven track record of achieving critical regulatory milestones, including Breakthrough Device Designation and resolving complex FDA issues. This blend of scientific acumen and hands-on submission success makes him an invaluable strategic partner for medtech innovators.
Certifications & Trust Signals
- 16 years experience
- 50 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- This consultant is ideally suited for medtech companies developing innovative Class II and Class III devices, particularly in the cardiovascular, neurology, radiology, and IVD sectors. They are an excellent fit for companies navigating complex regulatory pathways such as PMA, De Novo, or seeking Breakthrough Device Designation. Startups, SMEs, and large medtech firms looking to establish robust QM
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), PMA
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
16
Num510k Submitted:
50
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
cardiovascular, neurology, radiology, ivd, other
Technology Types:
implantable, ivd_test, combo_product
Accepting New Clients:
No
