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​Applied Technical Services provides reliable technical file preparation support services for Class I and Class II medical devices. Bringing a device to market requires precise documentation and a clear regulatory strategy.

We help clients with this through our thorough documentation of our medical device testing services, minimizing the risk of remediation.

​What Is a Medical Device Technical File?

​A technical file is a comprehensive dossier covering a device’s classification, design, intended use, performance, clinical data, and risks. It demonstrates regulatory compliance and evolves from development through clinical evaluation, validation, and post-market activities. Since regulations vary by region, clients must understand the specific requirements of their target markets to ensure successful technical file submissions.

​What is Technical File Gap Support?

​Gap analysis is a structured review comparing a submitter’s documentation and regulatory approach against regulatory standards and submission requirements. It divides the document into sections by subject, enabling experts to systematically identify and address issues and inconsistencies prior to submission.

Our technicians can address gaps by providing thorough documentation of our provided testing.

​More About Our Technical File Preparation Support Services

​Our experts offer technical file preparation support services. We streamline device approval by helping clients do the following:

  • Ensure product compliance with applicable standards
  • Provide thorough documentation of testing

​Why Choose ATS

Our experts combine regulatory expertise with practical technical knowledge. We prioritize compliance, clarity, and defensible documentation to ensure your technical file is well-prepared for review.

​Contact Us

Ready to test your medical devices for compliance? Call +1 (888)-287-5227 or submit an online inquiry now.

Customer Service Representative, Ready to Help Direct You to the People Who can Help

We’re here to help.

Our 5 Major Segments

Testing

Inspection

Calibration

Engineering

Forensics

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