Read all about it! The latest news from the medical technology experts
Dynamic enhancement of Ingeneus QMS for medical devices and biomedical applications
As part of a concerted effort to grow our services, Ingeneus is extending its Quality Management System to include the handling of sterile products. By including this capability, we will further establish rigorous tracking procedures of sterile products during the manufacturing process in addition to their post market release. Expansion into this area has beneficial flow on effects for our entire Quality Management System; translating into demonstrable quality improvements for our present and future clients.
The Australian Therapeutics Goods Administration (TGA) specifies that if a system or procedure pack is to be supplied as sterile, Ingeneus must obtain Conformity Assessment Certification from the TGA or CE Certification from an EU Notified Body. Concomitant to this process, Ingeneus will be utilizing standards ISO 11137-1:2006, 11137-2:2006 and 11137-3:2006.