Provision Consulting Group
★★★★★
5.0
/ 5
•
33 reviews
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.
HQ:
Chino Hills, United States
Languages:
English, Korean, Mandarin
Timezones:
US Pacific
Claim 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 Estar:
No
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
No
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
us_agent_fda
Jurisdictions:
US
Industries:
Medical Devices
Portfolio:
100+
Response SLA:
hours
Product Type:
devices
Annual Renewal Support:
Yes
Registration Support:
No
Recall Support:
No
Inspection Support:
No
Emergency Contact24x7:
No
Annual Renewal Reminder:
Yes
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