vault paragon group
Vault Paragon Group is a service group hosting quality systems for device sponsors and manufacturers.
We also provide regulatory guidance for sponsors looking to apply for device clearance with the FDA and commercialize in the US Market.
We focus on accelerating access to the medical device market for early-stage companies by providing Regulatory guidance/strategy expertise, hosting the QM system, and assisting in operational support activities under a monthly service agreement.
Regulatory:
VPG mitigates risk for sponsors and manufacturers by formally owning the liability with the FDA through entity registration for device clearance and device registration. Registration may include categories such as the manufacturer of record, initial importer, and specifier of record. VPG maintains both professional and product insurance.
Quality Management System (QMS):
VPG actively maintains a 21 CFR 820 compliant QM system. We also provide post market surveillance and vigilance to ensure product safety and efficacy.
Operations:
Flexibility and sourcing to meet each clients unique needs is achieved with continuous review and utility of our approved supplier list. This includes supply chain risk mitigation and diligent oversight of supplier activity and quality.
199 E. 52nd Street, Ste 240
Garden City
ID 83714
858-945-3651