6 Bold Predictions for Medical Device Quality in 2024
As we step into the new year, we asked our team members to share their insights by forecasting five daring trends in medical device quality for…
5 BOLD Predictions for Medical Device Quality in 2023
With the new year upon us, we asked our Founder/President, Kyle Rose, and our General Manager (Taiwan Branch), Andrew Wu, to peer into their respective crystal…
UKCA Mark Delay – How to Capitalize on the Extension
On October 21, 2022, the Medicines & Healthcare Products Regulatory Agency (MHRA) announced that they are adding a twelve-month extension to the current standstill period on…
Best Practices For a SaMD MDR Application
Software as a medical device (SaMD) is a rapidly evolving field, posing opportunities and challenges for device organizations and regulators. We would like to dedicate this…
What Should (and Shouldn’t) Go In a Technical File for MDR?
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.…
FDA ISO Harmonization: What Does It Mean, and What Should We Do Next?
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…
MDR Transition: Why the Change, and What are the Changes?
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…
5 BOLD Predictions for Medical Device Quality in 2022
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…
Preparing your QMS for EU MDR
This webinar was hosted by Kyle Rose, President of Rook Quality Systems. You will find this webinar helpful for understanding how Rook helps companies identify the…
Documentation impacted by EU MDR
For medical device companies selling in the EU, the May 2020 deadline for Europe’s new Medical Device Regulation 2017/745 (MDR) is coming up soon. Post this…