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Threat management documentation is A vital element on the technical file for medical devices. It showcases the systematic approach to determining, evaluating, and mitigating likely hazards linked to the device’s use.
This approach need to determine issues in advance of they grow to be serious and make sure corrective motion is taken, all although continuously checking the prolonged-term performance from the device.
It can be crucial to notice which the technical file really should be a residing doc, consistently current and taken care of to replicate any adjustments or updates into the device. This makes certain ongoing compliance with regulatory necessities and facilitates successful entry to vital information and facts.
Despite the fact that there are various attainable types, This can be an example of how the Bill of Substances (coupled with the BOM) could seem:
The eu Union needs a technical file or technical documentation to become submitted to display that a medical device is compliant with all applicable regulatory requirements.
As your total-company compliance lover, Certification Authorities can help you in gathering all necessary facts and compiling the Technical File or Technical Documentation. With in excess of twenty five several years of knowledge, you'll be able to rely on us to exhibit the conformity of the solution, enabling you to market it in the specified sector.
Info on many of the locations where by structure and producing activities are carried out, including style schematics.
Annex seventeen in the Get to regulation is made up of limitations on the amount of a material authorized in distinct articles.
If applicable, inside provisions adhered to make certain compliance Together with the directives and/or regaulations
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Merchandise Verification and Validation Information: In depth info on tests and evaluations done to confirm and validate the device’s effectiveness, safety, and trustworthiness. This will likely incorporate check experiences, medical investigation reports, and info from overall performance experiments.
Hazard assessment is a vital element for all goods put on any current market. A threat evaluation is made of a series of logical measures to empower, in a scientific way, the analysis and evaluation in the pitfalls connected to a product.
Very clear Firm and traceability of information within the technical file are of utmost relevance. It allows regulatory authorities to easily overview and recognize the contents with the file.