September 6, 2019

This podcast was hosted by Andrew Wu, the Software Consultant of Rook Quality Systems.

You will find this podcast helpful for understanding changes imposed on SaMD under new EU MDR. SaMD manufacturer will find this podcast helpful for clarifications on qualification and classification changes on SaMD, and action items to...

July 18, 2019

This is Part 2 of a two-part series focusing on FDA's Pre-Cert Working model. 

4. Streamlined Review: It is expected that software products that are considered for Streamlined Review are from organizations that have gone through excellence Appraisal, and thus these have demonstrated excellence in developing, testing,...

July 18, 2019

             The Pre-Cert program represents a new regulatory paradigm for FDA regulating future software as medical device (SaMD). To cope with shorter development cycles and unique opportunities that software products offer (i.e. address malfunctions quickly to reduce adverse events), the...

May 29, 2019

        Currently, we are witnessing a drastic regulatory shift as MDR (2017/745/EU) replaces MDD (93/42/EEC) and AIMDD (90/385/EEC), effective May 26th, 2020. As a result, some Software as a Medical Device (SaMD) companies who already have introduced devices on the market might be subject to more stringen...

December 13, 2018

This podcast was hosted by Andrew Wu, the Software Consultant of Rook Quality Systems.

You will find this podcast helpful for understanding how Rook helps SaMD companies ensure that their documentation, platform, and systems they establish during the design, development, and manufacturing of software aligns with regulato...

July 4, 2018

         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...

June 20, 2018

       In recent years, the medical device industry has become overwhelmingly impacted by digital health. According to the US Food and Drug Administration (FDA), products that fall under this category include devices such as mobile health, health information technology (IT), wearable devices, telehealth and tel...

September 5, 2017

Summary of Key Points

  • Software development process require a variety of process planning activities that would address how you design, implement, and maintain software throughout its lifecycle. 

  • Regulatory bodies require medical device software manufacturers to conform to a comprehensive list of guidelines, to ma...

April 27, 2017

Summary of Key Points

  • The key to address medical device software regulation starts with three questions: What does your software do? How do you plan to build it, and to test it?

  • Requirements are the cornerstone for building and maintaining software throughout its lifecycle.

  • The objective of regulatory agenci...

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[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

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