HR FEET is taking a new step forward in the quality and compliance of its products:<\/p>\n
from now on, every custom-made orthopedic insole will be accompanied by a declaration of conformity.<\/p>\n
This measure is part of the approach to holding custom-made medical device manufacturers accountable and strengthens our quality commitment to your patients and to our collaboration.<\/p>\n
The declaration of conformity is a regulatory document certifying that each medical device manufactured meets the essential safety and performance requirements defined by European regulations (Regulation (EU) 2017\/745).<\/p>\n
It guarantees full traceability of the manufacturing process, from prescription to delivery, and certifies that the materials, processes, and quality controls meet the required standards.<\/p>\n
In other words, it is the \u201cregulatory identity card\u201d of your insole: official proof that the device provided to your patient is safe, compliant, and manufactured in accordance with best practice.<\/p>\n
To strengthen transparency between the practitioner, the patient, and the manufacturer.<\/p>\n
To secure podiatric practice by ensuring that each device complies with European standards.<\/p>\n
To enhance your work as a prescriber by guaranteeing exemplary traceability.<\/p>\n
To anticipate upcoming regulatory requirements and maintain the high level of quality that HR FEET is known for.<\/p>\n
Each order of custom-made insoles will now be delivered with its specific declaration of conformity, linked to the manufacturing batch number.<\/p>\n
This document can be downloaded from “order management” and must be kept in the patient file, in accordance with the legal traceability requirements.<\/p>\n
This approach confirms HR FEET\u2019s commitment to supporting its partner podiatrists with a demanding, responsible, and sustainable approach to manufacturing custom-made medical devices.<\/p>\n","protected":false},"excerpt":{"rendered":"