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.
Buyer Snapshot
Best for
- Companies seeking FDA 510(k) submission support
- Manufacturers needing regulatory guidance in the US
How engagement typically works
- Consultative approach
- Expert analysis and strategic advice
Typical deliverables
- 510(k) submission strategy
- Regulatory compliance advice
- Analysis of FDA communications
Good to know
- Best when navigating complex or historical FDA regulatory issues.
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, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), 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), De Novo, PMA, 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
Engagement Models:
Consulting
