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FDA Q-Submission Program: What You Need To Know
Medical devices have traveled a long path throughout the past century, and we certainly believe that there are many more miles to go in this ever-evolving…
FDA eSTAR Program: Three Main Benefits
Medical Device companies are keenly aware of the difficulties and confusion that can surround medical device 510(k) and De Novo filings. With the Voluntary eSTAR Program,…
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…
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.…
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In December of 2021, the FDA issued two draft guidance documents for transition plans for medical devices that were issued Emergency Use Authorizations (EUAs) and for…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…
Peace of Mind At Your Fingertips: Digital Health Funding Explodes
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…