Medical Device – QSR Support

At Performance Validation, we commit to provide efficient, cost-effective, timely, and high quality medical device validation for new and existing equipment and processes, which not only meet regulatory requirements, but can also add value to your business. Our Medical Device Validation professionals will deliver your project with integrity and excellence, demonstrated through a focus on practical implementation of compliance and end user requirements – while never losing sight of your goals, scope, and priorities. Our goal is to provide you with the peace of mind with respect to the management and accomplishment of project work in which we have been entrusted to complete.

Performance Validation stays current with the latest industry standards and best practices such as current Good Manufacturing Practices (cGMP, 21CFR820), ISO13485, ISO14971,  and IMDRF’s (GHTF/SG3/N99). We have successfully qualified large, new production lines, as well as smaller upgrades to existing equipment. We’ve also validated new and existing process for our clients, including support during process development and execution of Design of Experiments. With years of experience in simple mechanical, complex automated, and manual manufacturing processes, Performance Validation is poised to deliver a right-sized and integrated solution to assist you in meeting your Medical Device Validation needs.

Regulatory compliance is at the forefront of Performance Validation professional’s minds in planning a medical device validation project. Knowing how to efficiently and effectively meet regulatory requirements and industry standards is one of our specialties. Performance Validation can comply with, and adapt to, your processes and procedures and/or implement Medical Device Validation methodologies to make the project a success.

Performance Validation can manage and support your entire Medical Device Validation project and/or any component of your equipment or process upgrades. Need help? Contact Performance Validation to discuss how we may help you on your next project or to request additional information on our service offerings and experience.

Services offered:

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.

Validation Project Planning & Implementation

Performance Validation professionals plan Medical Device Validation projects, small and large, from defining equipment requirements and installation qualification to final assembly process and software validation. We work to find a cost-effective, high-quality solution for your validation needs while achieving regulatory compliance.This is achieved by working with you and your Subject Matter Experts (SMEs) to not only understand your products, equipment, and processes, but also understand any company-specific requirements you might have. We bring our knowledge and experience in medical device manufacturing validation to drive documented justification for focused testing and streamlined document development and execution. This controls the validation cost and time required for your project without sacrificing quality or compliance.

Verification and Validation Project Planning Activities/Deliverables Include:

  • Validation Change Plans for Upgrades to Existing Production Lines
  • Participation in Risk Analysis Development
  • Project Management (including Expense, Project, and Milestone Management)

Manufacturing Equipment Qualification

Performance Validation professionals understand the need to clearly define and document equipment requirements that are reasonable, objective, and provide clear acceptance criteria which, when tested
and accepted, leave you with qualified equipment that does what you need it to!
Our professionals work with you throughout the equipment qualification phase and provide high-quality user requirement documents and functional specifications for your custom, complex, or simple off-the- shelf equipment. Using these documents, we develop and provide Installation Qualification protocols for your review and approval. These IQ documents ensure your equipment or system not only meet the requirements, but also function as intended in a validated state. This can be done by not only checking that calibration and preventative maintenance procedures are in place, but that they are accurate and appropriate.

Types of equipment we have qualified include:

  • Laser Markers
  • Laser Welders
  • Resistance Welders
  • Torque Drivers
  • Vision Systems & Automated Inspection equipment
  • Packaging Equipment
  • Manual and automated presses
  • Custom Fixtures used in Manual or Automated Processes
  • Complex, Automated Equipment with Custom Software
  • Custom, Complex Equpment

Process Validation

Performance Validation professionals not only develop and execute high-quality Operational and Performance Qualification protocols, we can also assist in the Design of Experiment and testing strategy.
We work with your experts to help understand, document, and test your manual, automated, and special processes to ensure your development and process is compliant.

Types of Processes we have Validated:

  • Laser Marking
  • Laser Welding
  • Resistance Welding
  • Ultrasonic Welding
  • Heatstaking
  • Adhesive Cure Time
  • Manual Processes
    • Soldering
    • Packaging

Quality System Regulation (QSR) Support

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.

  • 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.

Types of Medical Device Projects we have Completed