Palo Alto Health Labs
Palo Alto Health Labs (PAHL) is a digital health consultancy in Palo Alto, California. It offers fractional CTO leadership, healthcare AI, SaMD planning, HIPAA guidance and medical data labeling.
Palo Alto Health Labs (PAHL) is a digital health consultancy based in Palo Alto, California. It offers fractional CTO leadership, healthcare AI implementation, SaMD planning, HIPAA compliance guidance, study design and technical due diligence, plus medical data labeling: dataset sourcing, de-identification, clinical annotation, physician RLHF data and medical AI evals.
HQ:
Palo Alto, United States
Languages:
English
Timezones:
PT
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, SaMD, Digital Health
Flags:
smd_samd
Included services:
FDA 510(k) strategy, SaMD planning, healthcare AI implementation, HIPAA compliance guidance, study design, technical due diligence, medical data labeling
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, Pre-Sub / Q-Sub Preparation
Pathways Supported:
Traditional 510(k), Pre-Sub / Q-Sub
Device Types Supported:
Medical device, SaMD
Supports Estar:
No
Supports Rta Remediation:
No
Supports Predicate Research:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
No
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Technology Types:
Healthcare AI, Digital Health
Engagement Models:
Fractional CTO
Accepting New Clients:
Yes
