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Medical Device Software (MDSW) III – Validation
The design and development of the MDSW includes the verification and validation stage that is critical for its certification. The IEC 62304 guides you […]
Medical Device Software (MDSW) II – Classification
Once you know that the software with a medical purpose is considered a MDSW and it is covered by the Medical Device Regulations, you need […]
Medical Device Software (MDSW) I – Definition
Although new Medical Device Regulation (EU) 2017/745 – MDR is postponed for one year until the 26th May 2021, manufacturers are working to provide or […]
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Contexto En diciembre de 2019 se publicó la tercera edición de la ISO 14971:2019 Medical devices — Application of risk management to medical devices que sustituye […]
EUGMP Requirements on Sterile products … What’s next? EUGMP Annex 1 was first published in 1971 and the current version came into operation on 2009 […]
On September 19th 2019, the European Medicines Agency (EMA) notified all Marketing Authorisation Holders (MAHs) to evaluate the risk of the presence of nitrosamine impurities in […]
Although it could look like a simple issue, a difficult thing to decide about the Medical Cannabis is the classification of the product from a pharmaceutical […]
