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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...

GDPR- Changes in Data Privacy Protection Affects Multinational Businesses 

  This week, effective May 25th, 2018 the General Data Protection Regulation (GDPR) will be valid in the European Union (EU). This regulation harmonizes data privacy laws across Europe and replaces the current data protection directive 95/46...

Data Integrity- where GxP, IT-Security and Data Privacy come together

Data Integrity (DI), a vital part in the Compliance Framework of Life Science Companies, is mostly associated with GxP, but, it also applies to Information/IT-Security and Data Privacy.  Take patient data of clinical studies, for example.    Data Integrity in general ...

Data Integrity: Risks and Solutions

To ensure patient health and product quality, adhering strictly to Good Manufacturing Practice (GMP) is essential. One part of GMP, which is increasing in importance within the last few years due to higher FDA focus, is Data Integrity. Data Integrity means the overall...

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