The FDA is allowed to visit your company to perform an inspection. In the course of the visit they may bring some issue to your attention in the form of an observation (aka a 483). This article reviews what a 483 looks like, some of the more common issues flagged in medical device companies, and how to respond.
We invite you to download our paper on the topic of 483 Observations.
While using a singular ITSM tool may be simpler, many organizations utilize multiple for their unique features. This often results in Jira Service Management, ServiceNow, and Freshservice working in tandem. Integrating these tools can be harder than it appears, but...
Traditional engineers often view data as a byproduct of the design process. They store data in static PDF reports or miscellaneous CAD files. However, as we enter the era of digital engineering, that perspective is shifting. Today, product data is no longer just a...
The software development space is currently undergoing a significant transformation. At SPK and Associates, we have spent over 20 years helping engineering organizations navigate the complexities of ALM, DevOps, and regulated product development. We have seen the...
Introduction: Inside the Digital Thread Michael Roberts:Hello everyone, and welcome to today’s SPK and Associates blog entitled, Inside the Digital Thread: Real Stories from Integrated Engineering Teams. My name is Michael Roberts. I’m Vice President of Sales and...