HP&M
HP&M – FDA 510(k) & regulatory consulting
HP&M specializes in FDA regulatory consulting for medical device companies, providing expertise in regulatory strategy, premarket submissions, quality systems, risk management, and US agent representation.
About
HP&M specializes in FDA regulatory consulting for medical device companies, providing expertise in regulatory strategy, premarket submissions, quality systems, risk management, and US agent representation.
Additional information
### **Additional information**
- **Type:** independent
- **Company:** HP&M
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 15
- **Location:** US
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** The job posting indicates that HP&M is seeking an experienced regulatory expert. Without further information, it's difficult to assess specific strengths.
- **Unique value:** Without more information, it's impossible to determine the unique value proposition of this potential hire.
- **Ideal projects:** The ideal project would involve a medtech company needing regulatory expertise, but the specific type of company or project is unknown.
- **Confidence score:** 20/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special
- **Specialties:** regulatory strategy, risk management
- **Device panels:** general hospital, cardiovascular, neurology, orthopedic
- **Regulatory pathways:** 510k, de_novo
- **Type:** independent
- **Company:** HP&M
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 15
- **Location:** US
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** The job posting indicates that HP&M is seeking an experienced regulatory expert. Without further information, it's difficult to assess specific strengths.
- **Unique value:** Without more information, it's impossible to determine the unique value proposition of this potential hire.
- **Ideal projects:** The ideal project would involve a medtech company needing regulatory expertise, but the specific type of company or project is unknown.
- **Confidence score:** 20/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special
- **Specialties:** regulatory strategy, risk management
- **Device panels:** general hospital, cardiovascular, neurology, orthopedic
- **Regulatory pathways:** 510k, de_novo
Key Highlights
- The job posting indicates that HP&M is seeking an experienced regulatory expert. Without further information, it's difficult to assess specific strengths.
- Without more information, it's impossible to determine the unique value proposition of this potential hire.
Certifications & Trust Signals
- 7 years experience
- 15 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal project would involve a medtech company needing regulatory expertise, but the specific type of company or project is unknown.
HQ:
US
Languages:
English
Timezones:
ET
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, 510(k) RTA Remediation / Refuse-to-Accept Fix, FDA Meeting Support (Q-Sub / Type C), Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, Labeling Review for Submission (510(k)/De Novo/PMA), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), Pre-Sub / Q-Sub
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
7
Num510k Submitted:
15
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general hospital, cardiovascular, neurology, orthopedic
Accepting New Clients:
Yes
Supports Estar:
No
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Product Code Experience:
JKA, PJC
