- Spark Holland BV achieves ISO 13485 certification
Product News: Spark Holland BV achieves ISO 13485 certification
08 May 2007In April 2007 Spark Holland BV received the ISO 13485:2003 certificate from its notifying body, the KEMA. This ISO quality system is designed for companies delivering to the clinical market.
Spark has recently registered its Symbiosis™ Pharma system as an FDA Class 1 Medical device and certified it as a CE IVD device. The Symbiosis system accepts raw biological samples, like plasma or urine, cleans them up, performs LC separation and then injects it directly into the MS. This high level automation provides better quality data, lower cost per sample in a GLP – 21 CFR part 11 compliant environment.
President Rob Castien said: “We believe MS technology has a great future in the clinical market. It’s for that reason we recently announced our co-marketing agreement with Waters in this area. In order to better serve this market we felt we had to have the mentioned registrations. That required us to certify our organization according to ISO 13485:2003 and grow to the next level. We are very proud to have achieved this within a 6 months period, indicating that our ISO 9001:2000 implementation was already very solid.”
The improved design and risk assessment procedures will also benefit customers outside the clinical market as overall quality and responsiveness of the Spark organization will be driven to new heights.