quality management system
PendraCare recognizes its responsibility as a manufacturer and developer of quality products. To this end, PendraCare has developed and documented a Quality Management System which is maintained and enforced by our Quality Assurance team.
Our Quality Management System complies with the international standard EN-ISO 13485:2012, Medical Devices – Quality Management Systems – Requirements for regulatory purposes, the current Council Directive 93/42/EEC and Quality Systems Regulation QSR (21 CFR part 820). Management of PendraCare and all of its employees are committed to maintain the excellent quality of our products, to meet our stated quality objectives, and to comply with applicable regulatory requirements, as defined in our Quality Policy.
- Quality Management System per European Council Directive 93/42/EEC (certificate 2020764CE01, 2020764CE02 and 2020764DE01)
- Quality Management System per (current) EN-ISO 13485:2012 for the development, manufacturing and distribution of cardiovascular catheters (certificate 2086817)
- Quality Management System per (current) CAN/CSA ISO 13485:2003 for design and development, manufacturing and distribution of Cardiovascular catheters and Urodynamic catheters (certificate 2171345)
Certificates are issued by PendraCare's Conformity Assessment Body (International) / Notified Body (Europe) DEKRA Certification B.V.