Applied Technical Services is a trusted provider of medical device technical file risk analysis services. The medical device industry is steadily expanding, and manufacturers of new devices will need reputable consultants to help them submit their devices to the FDA and the European Union (EU). Our medical device consultants have extensive experience helping clients navigate the lengthy path to medical device approval.
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 and EU require technical files to demonstrate a subject device’s eligibility for sale. In the US, the FDA relies on this documentation to ensure compliance with the 510(k) pathway, while the EU uses it to confirm compliance with the Medical Device Regulation (MDR).
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 and EU. 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. 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 identify documentation gaps, strengthen risk management strategies, and ensure compliance with EN ISO 14971 and additional US/EU regulatory requirements. We help clients minimize approval delays, improve review readiness, and ensure the compliance of their technical files.
Contact Us
For more information about our medical device consulting capabilities, complete a web request form or call +1 (888) 287-5227.
