Blog
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…
Preparing For Your First FDA or ISO Audit
Our recent blogs on preparing for your first FDA inspection and/or ISO audit generated a lot of interest, and a lot of follow-up questions from emerging…
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
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In December of 2021, the FDA issued two draft guidance documents for transition plans for medical devices that were issued Emergency Use Authorizations (EUAs) and for…