SPK and Associates co-founder Chris McHale previously spoke with PLM expert Oleg Shilovitsky, founder of BeyondPLM.com, to get his top three product lifecycle management (PLM) predictions for 2015. Now they are teaming up monthly to discuss relevant industry items...
In episode five of our podcast series "Can IoT Jump These Five Hurdles?", SPK's Director of Strategy, Rajiv Mistry, discusses systems standards and regulation challenges that could impede IoT's future growth and effectiveness. Think VCR v.s. Betamax or Blu-Ray v.s....
For more than two decades, it has been SPK and Associates' privilege to support our clients’ varied engineering and systems integration needs. We're grateful for the opportunity to be useful to them all, in their various markets. We support a gamut of needs: From...
The use of open source software (OSS) within the medical device industry is a double edged sword. On one end of the spectrum, you have freely available code that is available for the world to scrutinize. In the process, one would hope that bugs are more easily...
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...
In the three previous rounds of this Metrics, Metrics, Metrics series, I discussed gathering metrics, and building Reports and Charts in PTC Integrity Lifecycle Manager. In this article, we will discuss how you can take various charts, reports and queries and...
Almost a year ago, I wrote about 10 Pitfalls that Can Impact VMware Performance. I thought I’d revisit this topic, provide some specific situations I've encountered over the past year, and explain what I've learned from them. You may have already taken the advice of...
In the fourth episode of our podcast series “Can IoT Jump These Five Hurdles?”, SPK & Associates’ Chief Strategy Officer, Rajiv Mistry, explains the challenges of IoT total cost of ownership and return on investment. To see all published episodes, scroll down this...
Last week, SolidWorks held its annual conference, SolidWorks World 2018, in Los Angeles where over 5,000 engineers, manufacturers, educators and enthusiasts attended. Many who could not attend streamed the conference sessions online and scanned the 5000+ tweets that...
A critical business challenge for medical device manufacturers as they scale is getting products to market quickly while supporting existing products and meeting FDA Quality System Regulation (21-CFR-820) requirements. To achieve this effectively, Product Development...
The release of the FDA final rule on Unique Device Identification (UDI) is expected this summer. Here are five things you need to know: 1. What is the UDI Rule? In July 2012, the FDA proposed a rule requiring medical device manufacturers to label their products with...
As of July 22, 2014, the RoHS (Restriction of Hazardous Substances) Directive must be observed for first time distribution of all medical devices to the full extent. Furthermore, all products with a CE marking must also be RoHS-compliant. ROHS 2 Compliance Changes at...