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 Being Said, Not What You Will Ask Next
The best medical device auditors are first and foremost great listeners.… » Read more
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 many suppliers you have, it’s vital (and required by ISO 13485) that you monitor their performance and conduct regular evaluations.… » Read more
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, many of these same wannabe medical device companies have a robust Lean and Six Sigma culture, where a large percentage of employees hold Green Belts.… » Read more
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 one example of the risks that connected devices pose to patient safety according to a recently published paper by the US Department of Health and Human Services (HHS), which oversees FDA.… » Read more