Medical Device Validation

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

Quality System Regulation (QSR) Support