Services: FDA Approval

The shortest path to regulatory compliance

For companies making clinical decisions or medical devices, FDA approval can be a time-consuming and costly final step. Mass Spectra offers a variety of services to help you quickly and cost effectively comply with FDA regulations and approval processes, including:

• 510(k) pre-marketing submission. For manufacturers of medium- and high-risk medical devices, Mass Spectra can guide you through all aspects of the 510(k) submission and review process, including the preparation of a final safety and efficacy summary.

• CLIA laboratory certification. Mass Spectra can help you comply with Clinical Laboratory Improvement Amendments (CLIA) quality standards, which ensure the accuracy, reliability, and timeliness of patient test results. We navigate CLIA complexity categories as well as the application, training, and certification process.

• GMP and GLP standards. Mass Spectra can help you interpret and achieve GMP and GLP quality standards in all aspects of your business. Good Manufacturing Practice (GMP) standards minimize contamination and errors to ensure that your products are safe, pure, and effective. Good Laboratory Practice (GLP) standards generate reliable test data on the safety of chemical substances.

• 21 CFR acceptance. Successful compliance with 21 CFR Part 11 regulations, in particular specifications for electronic signatures and records, hinges on securing the authenticity of the data you generate. Mass Spectra can protect the integrity, security, and traceability of your electronic records.