We have an extensive experience in the Medical Devices´ sector, providing a global support in relation to the product and to the facilities (quality system, qualifications, validations, activity license ...)
CE Marking: Technical and regulatory aspects for the application
Medical devices, other than customized products or research products, shall bear the CE mark of conformity to show their compliance with the current directives and shortly the Regulations, so that they can circulate freely within the European Union and can be put into service according to its intended purpose.
Quality system: ISO 13485: 2016
We put at the service of the client experts to support in complying with the requirements established in the regulations of medical devices.
Software and apps validation
We put at the service of the client experts in the Verification and Validation of the Software as a Medical Device - UNE EN 62304 - Medical device software. Software cycle processes.
Qualification of the production equipment
The qualification of the production equipments such as compressors, capsulators, fluid air beds, packaging lines, granulators and reactors are fundamental within the validation plan since they directly affect in the quality of the final product.
Post commercialization follow-up
In accordance with the current legislation, all manufacturers must have a post-commercialization monitoring system appropriate to the type of risk and the type of medical device.
The purpose is to demonstrate that the products manufactured in series continue complying with the principles of safety and operation with which they were authorized.
Commercialization in USA - FDA requirements
In order to export the medical devices and their subsequent commercialization in the United States, we must register the product with the FDA.
QUALIPHARMA MEDICAL DEVICES, together with its partner located in the USA, supports its clients in all the activities necessary for the commercialization of medical devices.
Discover our training plans related to Regulatory Affairs and Medical Devices. Customized training, "in-company or online" on any aspect related to our work and customer needs.