Our Medical Device Services

For more than a decade, PV has supported Fortune 500 companies, foreign subsidiaries, and smaller medical device companies in the following areas:

Validation Project Planning and Implementation

Performance Validation helps with small and large projects, from defining equipment requirements and installation qualification to final assembly process and software validation. Key areas of support include:

  • Macro validation planning and reports
  • Risk analysis development
  • Project management (including expense, project, and milestone management)

 Our three-step process:

  1. Work with subject matter experts to understand your products, equipment, processes, and any unique company requirements.
  2. Find cost-effective, high-quality, and regulatory-compliant solutions.
  3. Drive documented justification for focused testing and streamline the document development and execution process.

The result? Reduced costs and shorter project timelines—without sacrificing quality or compliance.

Equipment Qualification

Performance Validation understands the need to clearly define and document equipment requirements that are reasonable, objective, and testable so that your qualified equipment is effective when you need it. We also develop and execute Installation Qualifications to ensure your equipment is appropriately designed and is installed to meet maintenance, cleaning and use requirements as well as regulatory requirements.

Types of equipment we have qualified include:

  • Laser markers
  • Laser, ultrasonic, and resistance welders
  • Torque drivers
  • Laboratory equipment
  • Vision systems and automated inspection equipment
  • Packaging equipment
  • Manual and automated presses
  • Injection molding equipment
  • Custom fixtures used in manual or automated processes
  • Complex, automated equipment with custom software
  • Custom equipment
Process Validation

Performance Validation not only develops and executes high-quality Operational and Performance Qualification protocols, we can also assist with Design of Experiment and testing strategy. We work with your experts to understand, document, and test your manual, automated, and special processes for compliance.

Processes we have validated include:

  • Laser marking
  • Laser, ultrasonic, and resistance welding
  • Adhesive curing
  • Soldering
  • Packaging
  • Injection molding
Test Method Validation

Performance Validation recognizes the need to ensure your test method is suitable for its intended use. We work within your quality system to develop a sampling plan, acceptance criteria, and statistically analyze results.

Test Methods we have validated include:

  • Tensile testing
  • Compression testing
  • Automated measurement systems
  • Visual inspection
Quality System Regulation (QSR) Support

Performance Validation’s programs have been successfully implemented and evaluated through audits (internal, FDA, and ISO certification/recertification), allowing our clients to transition from Official Action Indicated to No Action Indicated on subsequent inspections.

We use a best-practice approach that incorporates ISO concepts, while helping to develop procedures that address other regulatory needs, including management controls, design controls, corrective and preventive actions, and production and process controls.

Auditing processes or elements we’ve helped refine include:

  • Validation program governing documents (e.g., 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
  • Qualification and validation packages
  • Design history file
  • Change control
  • Batch record reviews

Link to Medical Devices Main Page