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Core Compliance LLC

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Core Compliance provides expertise for FDA Regulatory compliance and consulting for an ISO-compliant management system customized to your company’s unique operating methods. ISO consulting for ISO 9001, ISO 13485, ISO 17025, ISO 20000, ISO 27001, AS9100,ISO 14001, OHSAS 18001, R2 RIOS NIAD & e-Stewards Certification.

Our FDA Regulatory consultants can provide training or assist and manage the following key Medical Device compliance requirements:
ISO 13485:2016 QMS Medical Devices Update ISO 14071:2012 Risk Compliance
CAPA (Corrective and Preventive Action)
Nonconforming Product Procedures 21 CFR 820:90
Complaint Procedures
Medical Device Reporting Procedures
Regulatory Submissions
483 responses
Warning Letters
Complaint Handling Procedure

See our website

Company Details

Address
180 S Main St., #201
Bountiful, UT 84010

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Categories

Regulatory & Quality Control > ISO 13485 Consultants
Regulatory & Quality Control > ISO 9000 Certified
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Med Device