Final Siemens Medical Systems' facility regains FDA clearance:
This article was originally published in Clinica
Siemens Medical Systems' electromedical group has received US FDA clearance to resume imports of ventilator systems from Siemens-Elema in Solna, Sweden. This means that all of the group's manufacturing facilities have now regained agency clearance following enforced suspension of manufacturing and shipments to US customers pending GMP improvements in early 1994 (see Clinica No 593, p 1). President and CEO Robert Dumke notes that the company has made a multi-million dollar investment in upgrading its manufacturing processes and quality measures worldwide under an agreement with the FDA.