Misbranded & Adulterated Medical Devices – FDA
This article provides brief information on misbranded and adulterated medical devices.
Safety-Critical Components: General Information & Relevant UL Standards
This post contains information on what safety-critical components are and a list of UL standards applicable to various safety-critical parts implemented in the design of electrical equipment.
11 Severe FDA Compliance Actions & Penalties
This article provides information on all FDA’s compliance actions and penalties, including product recalls, disqualification, civil money penalties and seizure.
Understanding the BXM Method
This article clarifies what the BXM method is and why medical device manufacturers should use it when performing risk management.
What is Pre-control and Positrol Verification?
Pre-control and positrol are two methods manufacturers need to use to verify the supplier quality process performance. This article provides readers with brief information on each of these methods.
7 Elements Essential for Product Liability Prevention
Product liability prevention is about understanding what to do and how to do it to achieve product safety excellence. For that reason, this article provides information on what product liability is and how to prevent it.
Assessing Product Design for EMC Compliance – Checklist
This checklist helps EEE manufacturers assess the design of their electrical products for EMC compliance.
Top EEE Constructional “Rules of Thumb” Regarding EMC Compliance
This article provides readers with a list of the best EEE constructional practices for ensuring EMC compliance.
Understanding REACH
This article provides information on the REACH Regulation and what duty holders need to do to register a chemical substance with ECHA.
Usability Engineering in Medical Devices: Definition, Standards & Tools
This article focuses on usability engineering in medical devices. Information regarding relevant safety standards is also provided.
