In the past, medical device design focused on a standalone unit or a group of a couple devices that worked together. While that was a great idea, the number of compatibility issues that could occur also blocked connectivity to other devices. With the stream of new...
As humans, we depend on feedback. Everyone likes feedback, whether a glance in the mirror, a friendly compliment or financial reward for a great job. Now thanks to the advancement of medical device design, high tech trends, and use of micro-computers, you can get...
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...
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...
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...
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...
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...
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...