Overview of ISO 13485:2016 ISO 13485:2016 is the industry standard for quality management systems for medical devices. Medical device specification developers, manufacturers, and distributors seek certification…
European regulations require manufacturers to create and maintain a technical file as a prerequisite to submitting a Declaration of Conformity, allowing products to be CE marked.…
In December of 2021, the FDA issued two draft guidance documents for transition plans for medical devices that were issued Emergency Use Authorizations (EUAs) and for…
March 2022 is a momentous time for RookQS, as it officially marks our ten-year anniversary as a company. To celebrate, we’ve launched a new website with…
The FDA has announced that their current quality system regulation will be replaced by one incorporating references to ISO 13485:2016. This is a major change in…
Changes to European regulations have sparked a lot of talk about new requirements. Around the globe, many wondered what these changes meant, and how they would…
To say that the Covid-19 pandemic has changed our lives is a major understatement. Since the outbreak, we’ve all experienced fear, anxiety and some form of…
In our upcoming webinar for emerging medical device companies, we will elaborate on these five bold prophecies, enabling you to peer into our crystal ball and…
As the end of the year rapidly approaches, many companies are rushing to get their internal audits completed before 2022. The internal audit process is critical…
As noted in Part I, last week the FDA released a long-awaited updated guidance document regarding the Content of Premarket Submissions for Device Software Functions. This…