Whether you are subject to the regulatory requirements for Medical Devices and need to comply with the Quality System Regulations and ISO13485, or whether you voluntarily implemented an ISO9001 system to generate efficiencies and improve customer experience, implementing a best-in-class Audit program is key to your Quality operations. Is your Audit program up to the task?
Do you know why some processes are more “Special” than others? Process validation is an essential part of establishing a manufacturing process. Jean Boudaud takes a detailed look at what’s involved and demystifies all that IQ/PQ/OQ stuff.
At the Irish Medtech Global Access conference in Galway this week, a common theme emerged: planned transitional arrangements schedules for ISO 13485:2016, the European Medical Device and IVD regulations and the MDSAP audit program will combine to create a Perfect Storm which will challenge their resources of Regulatory agencies and assessment bodies and manufacturers alike. You may think things are getting busy now, but in reality we are in the calm before the storm. Are you ready?
China’s CFDA is flexing its muscles, CFDA leadership, speaking at CIMDR in Chengdu last month set out how the CFDA is stepping up postmarket monitoring of manufacturers and cracking down on submission fraud. We look at some of the highlights.
Australia’s Therapeutic Goods Administration (TGA) has introduced new regulations to require online notification within 2 months of Australian manufacture or the importation of a custom made device. Custom devices are wide ranging from simple dental appliances to 3D printed implants. Read on to learn about the TGA requirements or join a workshop on 3D printing in medicine.
Just in case you missed it – the long awaited 2016 update to ISO 13485 was published at the end of February. This revision is a big shake up of the venerable devices quality standard. It’s going to need time, effort and planning for transition to the 2016 edition. Join us in Adelaide for an intensive workshop on how to make the change.