SMART quality & compliance
Risk Management for Medical Devices: ISO 14971:2019
What types of risks are covered by Risk management? It covers the harms related to patients, users or/and environment. What is the difference between Design controls and Risk management? Design Controls prove that the Medical Device is safe, effective and meets the indications for use, and help reduce product risks. In parallel, Risk Management intends to identify, evaluate, analyze, assess and mitigate potential product issues. Indeed, there is a correlation between these two notions, however, the perspectives are different. What are the steps of the Risk Management process? A risk Management file must include: Risk management Plan Risk Analysis…
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SMART quality & compliance
New Medical Device Regulations (MDR) demand Quality Management Systems (QMS) for Software as a Medical Device (SaMD)
“Innovation is the calling card of the future.” Anna Eshoo It is remarkable, alone in the iOS App Stores, there are tens of thousands of apps which are registered as Software as a Medical Device (SaMD). With the new Medical Device Regulations (MDR) becoming effective in 2020, the companies that have developed these apps will need to perform considerable upfront review and update activities because of changes to classification, and as a consequence of this, most will need to set up a Quality Management System (QMS) to support the lifecycle of their products. The major challenge for these innovative, often…
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