https://www.youtube.com/watch?v=Og6826J7EOo Video Transcript: I'm Carlos Almeida, VP of Engineering at SPK and Associates. I've spent most of my professional life doing software engineering. 25 years plus in the world of high tech in the electronic design automation...
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...
Executive Summary Our medical device customers report that up to 70% of new product innovation is being created in the software domain. This represents an increase in both volume and complexity. How do you navigate that complexity with the rigorous compliance...
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...
The beauty of business process automation How often have we entered the same information into two different systems and wondered, “Why do I have to waste my time doing this?” These are computers, aren’t they? Shouldn’t this information flow where it needs...
The importance of test management, especially in highly-regulated industries, cannot be overstated. Efficient management of testing requirements leads to safer products, effective production, and satisfied customers. The PTC Windchill Requirements Validation &...
An important part of creating any product intended for use in any regulated industry vertical is that the manufacturer should have identified all of the risks involved in using the device. Then, they must have done their best to mitigate those risks before their...
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...
Device manufacturers have until this summer to ensure their devices comply with the EU's Restriction of Hazardous Substances Directive – commonly called the RoHS Directive – to be able to earn CE Marking. In short, no RoHS compliance, no CE Marking, no selling in the...
Greater medical device interoperability and the adoption of commonly accepted standards could save the US in excess of $30B, suggests a West Health Institute report published in March. Lack of device interoperability creates significant waste and risk to patient...
With the push by big technology players (Cisco, Google, Intel, etc.) towards connectivity in everyday devices, cyber security is becoming more and more crucial. This push is even seen in medical device design as the industry begins to move toward cloud-integrated and...