JARRELL T.D. MCWILLIAMS
Medical Device Regulatory Expert | 25+ Years Experience | FDA, EU MDR, Risk Management, 510(k), ISO 14971
Highly accomplished medical device professional with 25 years of experience, including senior leadership roles at Bayer U.S. Expert in navigating complex FDA, EU MDR, and global regulatory landscapes, with a strong focus on Medical Device Risk Management (ISO 14971) and ensuring patient safety. Proven ability to align product development with evolving regulatory expectations, enhance product quality, and support global compliance through specialized consulting services. Adept at risk-based process implementation, leading cross-functional teams, and driving successful product certifications and submissions.
About
Highly accomplished medical device professional with 25 years of experience, including senior leadership roles at Bayer U.S. Expert in navigating complex FDA, EU MDR, and global regulatory landscapes, with a strong focus on Medical Device Risk Management (ISO 14971) and ensuring patient safety. Proven ability to align product development with evolving regulatory expectations, enhance product quality, and support global compliance through specialized consulting services. Adept at risk-based process implementation, leading cross-functional teams, and driving successful product certifications and submissions.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 25
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU
- **Client types:** large_medtech
- **Location:** United States (PA)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** With 25 years of experience, this consultant specializes in navigating complex FDA, EU MDR, and global regulatory landscapes for medical devices. Their regulatory expertise depth is demonstrated through successful management of multiple 510(k) submissions and adherence to EU Medical Device Regulations. This consultant boasts an impressive track record of ensuring regulatory compliance, product safety, and successful product clearance. Their strong foundation in engineering design and regulatory compliance, as well as experience in managing R&D Quality and leading compliance initiatives, equips them to effectively bridge the gap between engineering design and regulatory compliance. This expert's expertise in ISO 14971 for Risk Management, FDA 510(k) and EU MDR submissions, and IEC 60601 series for device safety and EMC testing further solidifies their value proposition for medtech companies. Their ability to develop Design Documentation, conduct Gap Analysis, and implement Risk-Based Processes makes them an invaluable asset for ensuring regulatory compliance and product safety.
- **Unique value:** This consultant's unique combination of FDA experience, device expertise, regulatory depth, and technical skills sets them apart as a valuable asset for medtech companies. Their ability to bridge the gap between engineering design and regulatory compliance, combined with their expertise in ISO 14971 for Risk Management and FDA 510(k) and EU MDR submissions, makes them a prime candidate for ensuring regulatory compliance and product safety. Their extensive experience in managing R&D Quality, leading compliance initiatives, and developing essential documentation for successful product clearance further solidifies their value proposition.
- **Ideal projects:** This consultant excels in working with large medtech companies, handling complex 510(k) submissions, and ensuring adherence to EU Medical Device Regulations. They are particularly suited for projects involving cardiovascular, IVD, and SaMD devices, as well as those requiring expertise in risk management, regulatory compliance, and product safety. Their experience in managing R&D Quality, leading compliance initiatives, and developing essential documentation for successful product clearance makes them a prime candidate for medtech companies seeking to expand into new markets or navigate complex regulatory pathways. Projects involving the development of Design Documentation, Gap Analysis, and Risk-Based Processes are also ideal for their skillset. To maximize their value, medtech companies should engage this consultant early in the product development process to ensure compliance with regulatory requirements and product safety.
- **Confidence score:** 80/100
- **Last analyzed:** Mon Jan 05 2026 15:36:24 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special
- **Specialties:** radiology, ivd, software-samd
- **Device panels:** radiology, ivd
- **Regulatory pathways:** 510k, post_market
- **Type:** independent
- **Years of experience:** 25
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU
- **Client types:** large_medtech
- **Location:** United States (PA)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** With 25 years of experience, this consultant specializes in navigating complex FDA, EU MDR, and global regulatory landscapes for medical devices. Their regulatory expertise depth is demonstrated through successful management of multiple 510(k) submissions and adherence to EU Medical Device Regulations. This consultant boasts an impressive track record of ensuring regulatory compliance, product safety, and successful product clearance. Their strong foundation in engineering design and regulatory compliance, as well as experience in managing R&D Quality and leading compliance initiatives, equips them to effectively bridge the gap between engineering design and regulatory compliance. This expert's expertise in ISO 14971 for Risk Management, FDA 510(k) and EU MDR submissions, and IEC 60601 series for device safety and EMC testing further solidifies their value proposition for medtech companies. Their ability to develop Design Documentation, conduct Gap Analysis, and implement Risk-Based Processes makes them an invaluable asset for ensuring regulatory compliance and product safety.
- **Unique value:** This consultant's unique combination of FDA experience, device expertise, regulatory depth, and technical skills sets them apart as a valuable asset for medtech companies. Their ability to bridge the gap between engineering design and regulatory compliance, combined with their expertise in ISO 14971 for Risk Management and FDA 510(k) and EU MDR submissions, makes them a prime candidate for ensuring regulatory compliance and product safety. Their extensive experience in managing R&D Quality, leading compliance initiatives, and developing essential documentation for successful product clearance further solidifies their value proposition.
- **Ideal projects:** This consultant excels in working with large medtech companies, handling complex 510(k) submissions, and ensuring adherence to EU Medical Device Regulations. They are particularly suited for projects involving cardiovascular, IVD, and SaMD devices, as well as those requiring expertise in risk management, regulatory compliance, and product safety. Their experience in managing R&D Quality, leading compliance initiatives, and developing essential documentation for successful product clearance makes them a prime candidate for medtech companies seeking to expand into new markets or navigate complex regulatory pathways. Projects involving the development of Design Documentation, Gap Analysis, and Risk-Based Processes are also ideal for their skillset. To maximize their value, medtech companies should engage this consultant early in the product development process to ensure compliance with regulatory requirements and product safety.
- **Confidence score:** 80/100
- **Last analyzed:** Mon Jan 05 2026 15:36:24 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special
- **Specialties:** radiology, ivd, software-samd
- **Device panels:** radiology, ivd
- **Regulatory pathways:** 510k, post_market
Key Highlights
- With 25 years of experience, this consultant specializes in navigating complex FDA, EU MDR, and global regulatory landscapes for medical devices. Their regulatory expertise depth is demonstrated through successful management of multiple 510(k) submissions and adherence to EU Medical Device Regulations. This consultant boasts an impressive track record of ensuring regulatory compliance, product safety, and successful product clearance. Their strong foundation in engineering design and regulatory
- This consultant's unique combination of FDA experience, device expertise, regulatory depth, and technical skills sets them apart as a valuable asset for medtech companies. Their ability to bridge the gap between engineering design and regulatory compliance, combined with their expertise in ISO 14971 for Risk Management and FDA 510(k) and EU MDR submissions, makes them a prime candidate for ensuring regulatory compliance and product safety. Their extensive experience in managing R&D Quality, lead
Certifications & Trust Signals
- 25 years experience
Buyer Snapshot
Best for
- This consultant excels in working with large medtech companies, handling complex 510(k) submissions, and ensuring adherence to EU Medical Device Regulations. They are particularly suited for projects involving cardiovascular, IVD, and SaMD devices, as well as those requiring expertise in risk management, regulatory compliance, and product safety. Their experience in managing R&D Quality, leading c
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
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:
25
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
radiology, ivd
Technology Types:
samd
Accepting New Clients:
No
