The regulation of Medical Devices and Health Products enforces thouroughness in the application of the regulations and the generation of supporting documentation.
The elaboration of software considered as a Medical Device or Health Product must conform with a variety of requisites defined in the regulations and standards of the Marketplace.
- From the 21 CFR 820 of the USA to the requirments of a Medical Device from the EMA.
For this, we can offer assistance in all of the following areas:
- Definition of a development methodology for applications to conform with ISO 62304
- Definition of a Quality System to manage all related activities of the system to conform with ISO 13485.
- Risk Management for Medical Device according to ISO 14971.
- In the case of commercial products, there is an obligation to elaborate documentation which is a requirement of various agencies, from the CE market of the European Union to the preparation of a dossier which complies with 501(k).