Applied Technical Services is a reputable provider of technical file gap support services for manufacturers of Class I and II medical devices. The medical device approval process is meticulous, designed to ensure the safety and effectiveness of new devices. The documentation from our testing services helps our clients ensure their medical devices meet the requirements for eligibility for sale in the United States and the European Union (EU).
Our medical device testing services fill file gaps by providing thorough records of the performed tests.
What is a Medical Device Technical File?
A technical file is a detailed document that contains pertinent information about a medical device’s classification, design, performance, safety, and regulatory compliance. The technical file is an ever-evolving document that changes throughout the device’s lifecycle as it undergoes additional testing, updates, and evaluations. The FDA and the EU require technical files for a device’s eligibility for sale in the US and European markets. Each regulatory body has its own specific requirements for technical files, with the EU’s requirements heavily relying on clinical evaluation and post-market surveillance, and the FDA’s prioritizing pre-market approval.
What is Medical Device Gap Support?
Technical file gap analysis is the systematic examination of a subject medical device’s documentation and regulatory pathway to ensure the manufacturer addresses any unfulfilled requirements before submission. The medical device submission process is extensive, so gap analysis is often conducted by section or theme, helping to condense the subject matter into more manageable groupings.
Our services support gap analysis by providing reliable testing with thorough documentation.
About Our Technical File Gap Support Services
Our medical device testing team provides comprehensive technical file gap support services by providing testing with thorough records and documentation. Our experts understand documentation’s importance when clients seek FDA approval.
Contact Us
For more information about medical device consulting services, call +1 (888)-287-5227 or submit an online request form.
