Applied Technical Services is a reputable provider of technical file gap analysis 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. Our services help our clients ensure their medical devices and associated documentation meet the requirements for eligibility for sale in the United States and the European Union (EU).
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 Analysis?
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.
About Our Technical File Gap Analysis Services
Our medical device consulting team provides comprehensive technical file gap analysis services tailored to each client’s unique regulatory pathway and product profile. We carefully review existing documentation to identify missing, incomplete, or inconsistent information that could delay approval, helping confirm the accuracy of every required element. We have expertise in global regulatory compliance and the resources to help clients meet FDA and EU MDR requirements.
Contact Us
For more information about medical device consulting services, call +1 (888)-287-5227 or submit an online request form.
