Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
Medical Device Engineering
CAPA: A Review of 21 C.F.R. §820.100 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...
Streamlining Design Controls For A Leading Medical Device Maker
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...
The Power of the Cloud – Med Device Company Boosts Operational Efficiency and Customer Satisfaction
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...
Leading Medical Device Company Achieves Major Efficiency Boost by Utilizing SPK’s SolidWorks CSV Expertise
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...
Medtronic & PTC Codebeamer Case Study
The Neuromodulation department of Medtronic is a global leader in medical technology. Recently, they implemented codeBeamer ALM to overcome issues. These were issues that their previous software ecosystem wasn’t able to efficiently address. The organization aimed to...
SPK Accelerates Fortune 100 MedDevice Product Sale
Our client is Fortune 100 Medical Device manufacturer. SPKAA acts as a product cybersecurity managed service provider for their hospital products which have embedded Windows or Windows OS. Fortune 100 MedDevice Problem For over 10 years, SPK has provided ongoing...