Our Process

With our three-step process, PV works with our client team to understand their products, equipment, processes, and any unique requirements. From there, PV can provide cost-effective, high-quality, and regulatory-compliant solutions. We focus on document justification for focused testing so the document development and the execution process can be streamlined. With this approach, PV can reduce costs and shorten project timelines all without sacrificing quality or compliance.

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.

The 3-Step Process

Services We Provide

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

Process Validation Expertise

  • Class I, II, and III medical device manufacturing
  • New production lines
  • Existing production line updates

Quality System Development

  • Validation program governing documents
  • Corrective and preventative action procedures
  • Production and process control procedures

FDA Remediation

  • Form 483 response and completion

Services for Process Validation

PV not only develops and executes high-quality operational and performance qualification (OQ/PQ) protocols, but our team also assists with design of experiment (DQ) and testing strategies. We work to understand, document, and test the client’s 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

Services for Test Method Validation

PV recognizes the need to ensure a test method is suitable for its intended use. We work with quality systems 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

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

Service for Connected Devices

Connected medical devices are already entering everyday life bringing the potential to deliver better patient care and improve operational efficiency. Medical device connectivity can help provide healthcare professionals with complete, accurate and current patient assessments on demand. At PV, we understand the importance of patient safety and offer Computer Software Validation and Software as a Medical Device (SaMD) solutions. In addition, PV has experience validating artificial intelligence (AI).