General

ISO 13485 – Insight into QMS Standard for Medical Devices

By Waqas Imam0 CommentsGeneral
The latest version of ISO 13485 primarily emphasizes regulatory compliance. For an organization seeking to show compliance to ISO 13485, it must meet all the standard’s applicable regulatory requirements. Therefore, it is important for both medical device manufacturing companies and medical start-ups to understand this standard’s regulatory requirements. The Quality…
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The MDR’s Usability Requirements

By Waqas Imam0 CommentsGeneral
Rules, regulations, and legislations are very necessary to keep the processes running smoothly. The EU has proposed its new Medical Device Regulations (MDR) replacing the old Medical Device Directive (MDD) although the implementation of MDR has been postponed till 26th May, 2022. The MDR proposes several usability requirements for the…
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Medical Device Software & SaMDs: A Crash Course

By Waqas Imam0 CommentsGeneral
When it comes to evolution, the technology always has the lead. With new ideas emerging nearly every day on the face of the world, technology keeps reshaping our lives, and innovations and software applications are one prime example of that. Whether it is economic, social, educational, or medical, software programs…
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