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[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

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[Webinar] Understanding the Medical Device Single Audit Program and How to prepare for it

This webinar was hosted by Kyle Rose, the President of Rook Quality Systems. You will find this webinar helpful for preparing the registration process with MDSAP program, which allow medical device manufacturers to have a single quality management system audit that meets the requirements of all participating Regulatory Authorities. The initial participating Regulatory Authorities include FDA (USA), TGA (Australia), MHLW (Japan), Health Canada (Canada), and ANVISA (Brazil). Please contact us at info@rookqualitysystems.com if you have any questions. Sponsored by #MedicalDeviceSingleAuditProgram

Software Development Process for Healthcare Applications

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 make sure that no unacceptable risk introduced to patients with respect to safety and effectiveness. Electronic QMS system can be a handy tool to achieve accurate documentation for regulatory audits and reviews. Developing software is never an easy task, but maintaining software throughout its lifecycle could be a greater challenge, particularly in healthcare industry. Of all the 3140 m

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