Listen and Learn: Develop These Soft Skills and Become a Better Medical Device Auditor

You’ve heard it many times before: “Great (insert any profession here) are made, not born.” The saying is especially applicable to auditors. Truly effective auditors seem to have an ability to effortlessly extract nuggets of good information from their interviewees. They know how to use certain techniques to dig deeper even when their subjects are less than forthcoming. While some auditors may find it easier than others to develop these soft skills, they are very learnable skills. Focus on What Is […]

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All Topics, Auditing

Monitoring the Performance of Your Medical Device Suppliers

Suppliers are obviously a critical component of your business. Thus, when things start to go poorly, it’s not just their problem – it’s your problem. There are a variety of reasons why medical device suppliers could get booted from your Approved Supplier List but, quite often, the manufacturer-supplier relationship goes south over issues involving product quality and missed delivery time frames. That’s why ongoing monitoring is so important as a tool to head off serious supply issues. Regardless of how […]

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Medical Device CAPA Owners Need Love Too! Creating a Problem-Solving Culture in Your Organization

There are two kinds of problem solving in the medical device world: 1 – Solving for improvements in effectiveness and efficiency 2 – Solving for corrective action/preventive action (CAPA) compliance The transition from #1 to #2 seems to perplex organizations entering the medical device arena for the first time. CAPA is too often seen as a burden, stealing valuable time from scientists and engineers who would rather focus on what they know best – designing and making new products. Ironically, […]

FDA Medical Device Cybersecurity: Understanding Your Basic Regulatory Requirements

A cyber-attacker gains access to a care provider’s computer network through an e-mail phishing trap and assumes command of a file server to which a heart monitor is attached. While scanning the network for devices, the attacker takes control (e.g., power off, continuously reboot) of all heart monitors in the ICU, putting multiple patients at risk. It defies logic why a hacker would want to intentionally harm patients, but this type of threat is definitely not science fiction. It is […]

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