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A sample of recently completed projects

  • Multiple 510(k) Submissions

  • Multiple Pre-Submission Questions with FDA

  • Full Quality System Implementation

  • FDA Establishment Registration

  • Product Classification

  • Software Validation support for software as a medical device product

  • Software Validation for a new medical device

  • Supplier Audit on behalf of an IVD client

  • cGMP Training for a Chemistry Laboratory

  • Quality System for the initial importer of an overseas manufacturer

  • Full Quality System Audit of a class II medical device manufacturer

  • Training  Delivery to the Oregon Bioscience Association’s BioCatalyst Program on Quality Systems, FDA Inspections and an Overview of the FDA.

  • On-Site Support during an FDA Inspection

  • Development and Implementation of ISO 14971 Risk Management for an IVD client and for a medical device client.

  • Implementation of Unique Device Identifier with FDA GUDID database

  • Quality System Gap Analysis and remediation plan.

  • Strategic Regulatory Plan for multiple 510(k) submissions.

  • Software Validation Remediation Plan for legacy software system.

  • CAPA, Complaint, Document Control and Training systems