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…
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…
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) is no longer an emerging vocabulary in 2022. With the rapid development of medical digitalization, medical devices are no longer…
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…
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…
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…