Provision Consulting Group
FDA 510(k) Regulatory Consulting Expert | Medical Devices | Provision Consulting Group
Provision Consulting Group (PCG) is a US-based FDA regulatory consulting firm with 12 years of experience, specializing in FDA 510(k) regulatory consulting for medical devices and other products. They offer expert guidance to help medical device companies successfully navigate FDA regulatory pathways and achieve 510(k) clearances. PCG serves clients globally and is dedicated to providing specialized support for 510(k) submissions.
About
Provision Consulting Group (PCG) is a US-based FDA regulatory consulting firm with 12 years of experience, specializing in FDA 510(k) regulatory consulting for medical devices and other products. They offer expert guidance to help medical device companies successfully navigate FDA regulatory pathways and achieve 510(k) clearances. PCG serves clients globally and is dedicated to providing specialized support for 510(k) submissions.
Additional information
### **Cruxi analysis**
- **Strength summary:** Provision Consulting Group (PCG) is a highly valuable regulatory partner for medtech companies, leveraging 12 years of focused experience to navigate the FDA clearance process. Their core strength is a deep mastery of the 510(k) pathway, supported by robust expertise in De Novo submissions, Q-Sub interactions, and IDEs. The firm demonstrates exceptional breadth, with proven capabilities across a wide array of device panels including Cardiovascular, Orthopedic, IVD, and SaMD/Digital Health. PCG provides a comprehensive, end-to-end service model that covers everything from initial pathway assessment and predicate analysis to full submission authoring and QMS implementation. This full-lifecycle support, combined with their global client reach, establishes them as a reliable and deeply knowledgeable firm for achieving commercialization goals.
- **Unique value:** Provision Consulting Group's unique value proposition is the powerful combination of deep specialization in the 510(k) process with an exceptionally broad expertise across a multitude of complex device categories. This allows them to act as a versatile, full-service regulatory partner, capable of managing the entire clearance journey from strategy to submission and QMS development. Their ability to deliver this end-to-end support across such a wide spectrum of technologies makes them a uniquely comprehensive and dependable resource for medtech innovators.
- **Ideal projects:** The ideal client for Provision Consulting Group is a startup or small-to-medium-sized medtech company preparing to enter the US market with a Class I, II, or III device. They are perfectly suited to guide companies developing technologies in complex fields such as cardiovascular, orthopedic, IVD, neurology, and digital health through the 510(k) or De Novo regulatory pathways. A company would realize maximum benefit by engaging PCG early in the product development lifecycle to establish a sound regulatory and testing strategy. The perfect project involves a need for comprehensive support, from initial classification and predicate analysis through to authoring the full submission and responding to FDA deficiencies. Established medtech firms seeking to outsource submissions for specific product lines to a capable, specialized team would also be an excellent fit.
- **Last analyzed:** Sat Jan 03 2026 00:28:11 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, qms, de-novo
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** general-hospital, regulatory strategy, cardiovascular, radiology, ophthalmic, clinical-chemistry, software-samd, other, hematology, ivd, orthopedic, neurology, dental, anesthesiology, pathology
- **Device panels:** general-hospital, cardiovascular, orthopedic, obgyn, ivd, wearable_digital, dental, general_surgery, neurology, radiology, gastro_urology, anesthesiology, other
- **Regulatory pathways:** 510k, de_novo, q_sub, ide
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### **Additional information**
- Type: firm
- Company: Provision Consulting Group
- Years of experience: 12
- Regions served: US, APAC, EU, CA, MEA
- Client types: startup, large_medtech, academic, sme
- Location: United States
- Availability: available_now
- **Strength summary:** Provision Consulting Group (PCG) is a highly valuable regulatory partner for medtech companies, leveraging 12 years of focused experience to navigate the FDA clearance process. Their core strength is a deep mastery of the 510(k) pathway, supported by robust expertise in De Novo submissions, Q-Sub interactions, and IDEs. The firm demonstrates exceptional breadth, with proven capabilities across a wide array of device panels including Cardiovascular, Orthopedic, IVD, and SaMD/Digital Health. PCG provides a comprehensive, end-to-end service model that covers everything from initial pathway assessment and predicate analysis to full submission authoring and QMS implementation. This full-lifecycle support, combined with their global client reach, establishes them as a reliable and deeply knowledgeable firm for achieving commercialization goals.
- **Unique value:** Provision Consulting Group's unique value proposition is the powerful combination of deep specialization in the 510(k) process with an exceptionally broad expertise across a multitude of complex device categories. This allows them to act as a versatile, full-service regulatory partner, capable of managing the entire clearance journey from strategy to submission and QMS development. Their ability to deliver this end-to-end support across such a wide spectrum of technologies makes them a uniquely comprehensive and dependable resource for medtech innovators.
- **Ideal projects:** The ideal client for Provision Consulting Group is a startup or small-to-medium-sized medtech company preparing to enter the US market with a Class I, II, or III device. They are perfectly suited to guide companies developing technologies in complex fields such as cardiovascular, orthopedic, IVD, neurology, and digital health through the 510(k) or De Novo regulatory pathways. A company would realize maximum benefit by engaging PCG early in the product development lifecycle to establish a sound regulatory and testing strategy. The perfect project involves a need for comprehensive support, from initial classification and predicate analysis through to authoring the full submission and responding to FDA deficiencies. Established medtech firms seeking to outsource submissions for specific product lines to a capable, specialized team would also be an excellent fit.
- **Last analyzed:** Sat Jan 03 2026 00:28:11 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, qms, de-novo
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** general-hospital, regulatory strategy, cardiovascular, radiology, ophthalmic, clinical-chemistry, software-samd, other, hematology, ivd, orthopedic, neurology, dental, anesthesiology, pathology
- **Device panels:** general-hospital, cardiovascular, orthopedic, obgyn, ivd, wearable_digital, dental, general_surgery, neurology, radiology, gastro_urology, anesthesiology, other
- **Regulatory pathways:** 510k, de_novo, q_sub, ide
---
### **Additional information**
- Type: firm
- Company: Provision Consulting Group
- Years of experience: 12
- Regions served: US, APAC, EU, CA, MEA
- Client types: startup, large_medtech, academic, sme
- Location: United States
- Availability: available_now
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), De Novo, Pre-Sub / Q-Sub
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:
No
Device Panels:
general-hospital, cardiovascular, orthopedic, obgyn, ivd, wearable_digital, dental, general_surgery, neurology, radiology, gastro_urology, anesthesiology, other
Engagement Models:
fixed_fee
Accepting New Clients:
No
