Don’t Wait – Schedule Your 2024 Internal Audit with RookQS Today!
As 2024 wraps up, many companies are scrambling to complete their internal audits before the end of the year. The internal audit process plays a vital…
Understanding How to Properly Evaluate Suppliers per FDA Requirements 21 CFR 820.50
Purchasing Controls and Supplier Evaluations are a critical component of quality management for medical device manufacturers, ensuring that materials, components, and services provided by third parties…
What To Do (And What Not To Do) When You Receive a FDA Audit Notice
Receiving an audit notice from the FDA can be a daunting experience, but it also presents a great opportunity for your medical device company to demonstrate…
Internal Audits & Annual Physicals: Is Ignorance Really Bliss?
What Do Your Annual Internal Audit and Annual Physical Have in Common? They both roll around once a year, and both are typically dreaded. Your annual…
Software as a Medical Device (SaMD) Audit Challenges
Software as a Medical Device (SaMD) is no longer an emerging vocabulary in 2022. With the rapid development of medical digitalization, medical devices are no longer…
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…
‘Tis the Season … for an Internal Audit
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…