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​Applied Technical Services is a trusted provider of medical device technical file risk analysis services to EN ISO 14971.

What is a Technical File?

​A medical device technical file is a comprehensive document that captures the full scope of a new device’s classification, design, intended use, performance, safety, and regulatory compliance. It consolidates essential subject matter, including design inputs and outputs, verification and validation data, manufacturing information, labeling, clinical evidence, and risk analysis, into a structured layout for regulatory review. The US requires technical files to demonstrate a subject device’s eligibility for sale. The FDA relies on this documentation to ensure compliance with the 510(k) pathway.

​Understanding Risk Analysis

​Risk analysis is the process of identifying a medical device’s potential hazards and determining the likelihood that they will result in harm. The EN ISO 14971 standard is universally recognized and applicable to devices being developed in the US. EN ISO 14971 guides medical device manufacturers in identifying hazards, estimating and evaluating risks, and implementing effective safety measures to reduce risks throughout a product’s lifecycle. It provides a structured, evidence‑driven framework that ensures devices meet essential safety expectations and is a critical component of risk management.

​About Our Technical File Risk Analysis Services

​Our technical file risk analysis services help manufacturers demonstrate the safety, performance, and regulatory compliance of their medical devices and ensure their risk controls are compliant with ISO 14971.  We help clients identify and evaluate device hazards, assess the likelihood and severity of potential harms, and verify that risk controls are implemented. We work alongside clients to ensure compliance with EN ISO 14971 and additional US regulatory requirements. We help clients ensure the compliance of their technical files.

​Contact Us

​For more information about our medical device analysis, complete a web request form or call +1 (888) 287-5227.

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