Blog
FDA eSTAR Program: Three Main Benefits
More than a year ago, we explained the main benefits of the FDA eSTAR Program for 510(k) and De Novo filings. This information remains accurate, and…
How To Prepare For Your First FDA Audit
The FDA just called notifying you of their upcoming site visit! Now what? An FDA Inspection Audit can occur at any time. Below are tips you…
MDR Transition and Technical Files: What You Need to Know
Recent changes to European regulations have sparked a lot of interest and intrigue, and even more questions. So, what specifically do medical device companies need to…
How To Prepare For Your First ISO Audit
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…
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’s ISO 13485 Transition Plan … What Does it Mean for Your Medtech’s Quality Plan?
In this episode of the Project Medtech Podcast, Rook Founder/President Kyle Rose and Duane Mancini discuss in detail the FDA’s ISO-13485 transition plan, when it was…
COVID-19 EUA and Enforcement Policy Transition Plans
In December of 2021, the FDA issued two draft guidance documents for transition plans for medical devices that were issued Emergency Use Authorizations (EUAs) and for…
Rook Quality Systems: Celebrating a Decade of Gratitude and Growth
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…
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…