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[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

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7 Questions about the European MDR Answered

This post was published by Jon Speer, the Founder and VP QA/RA at Greenlight Guru. The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace. If your company was already compliant with the Medical Devices Directive (MDD), don't be fooled into complacency - the MDR represents brand new regulations with a lot of changes. As a starting point for medical device companies, we've created this article where we answer the seven of the most important questions about the new MD

Importance of Software Testing on Software as Medical Device (SaMD)

As software is progressively becoming both an integral part of many medical devices and a standalone service in the healthcare industry, manufacturers are faced with the challenge of maintaining the quality of all software functionalities throughout the software lifecycle. The IEC 62304 concept of software development life cycle (SDLC) is the backbone for software validation. It is important for your company to understand that compliance with this standard and any other supporting standards will most likely be required by your regulatory body. Software testing plays an important role during the development of each phase in the SDLC. A typical testing program includes the following steps: Exa

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