IM3 Consulting Group

   Quality & Compliance

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The design, manufacture, documentation, distribution, complaint handling and servicing of finished medical devices is subject to FDA's Current Good Manufacturing Practice (CGMP) Regulations, detailed in 21 CFR Part 820, and ISO 13485:2016.  Virtually every aspect of a medical product from “cradle to grave” is subject to CGMP, including any design changes made after release of a product.  Our extensive background in CGMP extends across all aspects of the regulations, including the following:

·     Completion of Quality Audits (e.g., pre-QSIT audits; pre-audit of Quality Management System; preparation for For-Cause Inspections)

·     Review of Quality System Procedures

·     Review of Training Documentation

·     Design Controls (all phase gates)

·     Design Verification & Validation

·     Design Changes

·     Design History File

·     Document Changes

·     Purchasing Controls

·     Production & Process Controls

·     Process Validation

·     Inspection, Measuring, and Test Equipment

·     Receiving & Inspection

·     Acceptance Records

·     21 CFR Part 11 Compliance (electronic records)

·     Non-Conforming Product

·     Corrective and Preventative Action (CAPA)

·     Labeling

·     Packaging & Storage

·     Distribution & Installation

·     Device Master Record

·     Device History Record

·     Complaint Files and Investigations

·     Corrections & Recalls

·     MDR reports

·     Device Servicing

·     Preparation of a Response to Form 483 Observations (post FDA Inspection) and Warning Letters

·     Preparation of a Response to Notified Body Nonconformities

·     Consent Decrees