Our approach to medical device safety
For fifty years, Wimed has been operating in the field of assistive devices for older people and individuals with disabilities, working alongside professionals and healthcare facilities in the supply of medical devices intended for daily use. The experience gained over time goes hand in hand with a constant focus on the safety and quality requirements applicable to the products we manufacture and distribute. Protecting the health of end users and complying with the applicable regulatory framework are essential foundations of our activities. Within this context, Wimed operates in accordance with the European regulations governing medical devices, collaborating with orthopaedic providers and supply chain partners in full respect of their respective roles and responsibilities.
Discover our productsQuality and Regulatory Affairs department
Wimed, part of the Movi Group, has an internal department dedicated to Quality & Regulatory Affairs, responsible for overseeing and managing compliance with applicable regulations, including the EU Medical Device Regulation (MDR 2017/745).
The department’s activities are aimed at supporting the organization in the correct application of regulatory requirements throughout the entire lifecycle of the device, in line with the role played by Wimed as manufacturer and/or distributor.
The devices marketed by Wimed are subject to the checks and verifications required by applicable regulations throughout the production and distribution chain, in order to ensure compliance with the safety and performance requirements established by the MDR.
The purchase of Wimed devices, such as wheelchairs, beds, walking aids, bathroom aids, and liftchairs, therefore takes place within a system governed by harmonized European standards designed to ensure a high level of public health protection.
Areas of activities of the Quality & Regulatory Affairs team
Placing on the Market
Wimed operates in compliance with the obligations established for medical device manufacturers and distributors. Prior to placing products on the market, the verifications required by applicable regulations are carried out, including the assessment of documentation provided by other manufacturers, as set out by the MDR.
Technical documentation
The department manages the technical documentation required by regulations, including certifications, quality controls, labeling, instructions for use (IFU/manuals), and, where applicable, documentation related to clinical evaluation.
Suppliers and Manufacturers
Wimed selects and collaborates with suppliers and manufacturers that meet the requirements established by applicable regulations, in accordance with the qualification and monitoring criteria defined by the adopted quality systems.
Complaint management and Post-Market surveillance
In compliance with the MDR, Wimed manages complaints, incident reports, and post-market surveillance (PMS) activities in order to monitor the safety of devices placed on the market and to fulfill reporting obligations to the competent authorities where required.
Registration with the Ministry of Health
Wimed ensures the registration and updating of the medical devices under its responsibility in the Ministry of Health database, in accordance with the procedures and timelines established by Italian regulations.
MDR 745/2017:
Innovation and Responsibility
The EU Medical Device Regulation (MDR 2017/745) has redefined the system of responsibilities throughout the medical device supply chain, involving not only manufacturers and authorized representatives, but also distributors and other economic operators.
The MDR establishes specific verification and control obligations for distributors, who are required to act with due diligence before placing a device on the market. Within this framework, Wimed ensures that the devices it distributes comply with the applicable requirements at the time they are made available.
Orthopaedic providers and healthcare retailers that market medical devices also operate as distributors under the MDR and are required to comply with the obligations set forth by applicable regulations, in accordance with the responsibilities assigned to each economic operator.
