In the second episode of our podcast series "Can IoT Jump These Five Hurdles?", we transition from a broad introduction of these five hurdles to a deeper dive into each challenge facing the Internet of Things. Let's begin with the smart device itself and it's digital...
An important part of creating any product intended for use in the medical field is that the manufacturer should have identified all of the risks involved in using the device, and have done their best to mitigate those risks before their product ever sees a patient....
The value system and practices that embody Agile Software Development have been around for well over a decade, and have been touted as having "crossed the chasm" by organizations such as the Agile Alliance, Gartner, and Forrester Research. Numerous studies indicate...
Whether or not your in a heavily regulated industry, having a solid email archiving solution is an absolute necessity. Email’s importance in the workplace for the past decade-and-a-half is similar to the need of having a dial tone in years past. In addition, email is...
Product lifecycle management (PLM) systems have evolved from being custom-built, on-premise applications to cloud-based, off-the-shelf solutions. As adoption for PLM in the cloud increases, system validation approaches in FDA/GXP regulated industries have had to...
SPK and Associates leverage PTC’s Integrity platform to help Medical Device companies develop software efficiently while achieving IEC 62304 compliance.
This article reviews what an FDA 483 Observation looks like, some of the more common issues flagged in medical device companies, and how to respond.
Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends. One of the problem areas most often cited in company audits continue to be the CAPA system/program. This month we will take a look at some of the latest FDA...
SPK helps this global enterprise to boost product development efficiencies, increase compliance reliability, generate reports with a single click, and shave weeks off their development/release cycles. The Client A respected global medical device powerhouse, with more...
BackgroundA diversified medical device company has a leading position in the global endoscopy device space. In this market, the company generates growth and differentiates its products primarily through incremental innovations and investment in research and...
Background Apublicly traded medical device manufacturer with 33,000 employees and several international locations approached SPK and Associates for assistance in streamlining their validation processes. The validation process took months, but the customer wanted...