Medical Device – QSR Support

Quality System Regulation (QSR) Support

Performance Validation has assisted domestic and international Medical Device manufacturers in meeting the US FDA and ISO 13485 requirements. PV has assisted several large (Fortune 500) companies, foreign subsidiaries, and smaller medical device companies in the review, audit, and enhancement of their Quality Systems.

Services provided have included development, enhancement and implementation of:

  • Validation Program which provide an industry standard approach based on the concepts of GHTF, ICH, GAMP, ISPE, and ISO to meet the expectations set forth in the Quality System Regulations.
  • Development of Procedures that address other QSIT elements, including management controls, design controls, corrective and preventive actions, and production and process controls.
  • Auditing of client Quality Management System, and or suppliers including audits of:
    • Validation program (Governing documents such as production equipment qualification, facility qualification, process validation, cleaning validation, computer system validation, analytical equipment qualification and methods qualification).
    • Supplier assessments of new or current vendors.
    • Completed qualification and validation packages.
    • Design History File
    • Change Control
    • Batch Record Reviews

Programs developed on the behalf of our customers have been successfully evaluated by client internal audits, FDA inspection and ISO certification/recertification audits. These programs have allowed our clients to transition from Official Action Indicated (USFDDA) to No Action Indicated (USFDA) on subsequent inspections.

Medical Device Verification and Validation Support

Since 2005, PV has assisted several large (Fortune 500) companies, foreign subsidiaries, and smaller medical device companies with qualification of facility and manufacturing equipment, verification and validation of the manufacturing processes.

 

Services offered:

Performance Validation offers the following services related to Verification & Validation to support our Medical Device customers:

Verification & Validation Project Planning & Implementation

  • TBD

Process / Manufacturing Equipment

  • TBD

Automated Quality Systems

  • Trackwise
  • Supervisory Control and Data Acquisition System
  • Laboratory Information Management Systems
  • Please see our CSV Page for a complete listing of PV’s experience with automated systems.

Types of Med Device Projects we have Completed

  • Validation of Glucose Strip Manufacturing facility Midwest USA
  • Validation of Glucose Strip Manufacturing Expansion Puerto Rico
  • Validation of a DNA based Colorectal test Manufacturing Facility Midwest USA
  • Validation of a Facility Move for a Midwest USA Diagnostic Test Manufacturer
  • Validation of a Trackwise QMS System Midwest USA