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...
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...
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...
When a global leader in infusion therapy, pain management technology, and support was developing more complex systems, they required an effective design control solution to support those efforts. SPK stepped in to help the medical company implement Windchill...
When multiple employees of a Fortune 100 medical equipment manufacturing company reached out to us for support with workflow functions and permissions, we knew there was a better way. Rather than fixing the issues that would inevitably keep occurring with their...