The complexity of the European regulatory framework poses continuous challenges to the interested agents with the the innovation and variety of the sector, forces companies to be permanently updated.
Compliance with regulatory requirements for the market access of medical devices according to EU Regulation 2017/745 and IVD medical devicess according to EU Regulation 2017/746:
- General safety and performance requirements.
- Preclinical evaluation and biological safety.
- Clinical studies and clinical evaluation.
- Design validation.
- Post-market clinical follow-up.
- Electromedical equipment
- Software such as medical devices.
- Medical devices Manufacturer license according to AEMPS requirements
- Medical device Importer license for sanitary products according to AEMPS requirements
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