Planning is a recognised and vital step in the development of any medical device…. planning of design, manufacture, customer requirements … the list goes on. However regulatory requirements are often...
KD&A provide expert medical device and IVD regulatory guidance to help launch products and access new markets. Our services include regulatory strategy, product registration for Australian (TGA), EU (CE Marking),...
The TGA have introduced a new online MDIR System for sponsors and manufacturers which is accessible via their eBusiness system (also used to submit applications). The eBusiness system can only...
The International Medical Device Regulators Forum (IMDRF) began work on developing documentation to facilitate the Medical Device Single Audit Program (MDSAP) in Singapore in 2012. The Pilot Program is now...
2013 is quickly drawing to a close – ensure you carry out a regulatory and quality management system (QMS) tidy up within your organisation before the Christmas break is here....
Formal decisions which will shape the future regulatory landscape of the EU are yet to be made by officials. Significant change is on the horizon however it is difficult to...
Technical Documentation is a vital component of gaining regulatory certification for all medical devices, including in vitro diagnostic devices (IVDDs). Technical Documentation often called a Technical File, Design Dossier, or...
New Zealand (NZ)’s regulatory body for therapeutic goods, Medsafe, have issued a reminder to medical device suppliers to ensure they are suitability prepared for a recall should an adverse event...
The TGA have announced that a component of the medical device reforms outlined in the TGA blueprint will not go ahead. The initiative to record all devices included under a...
The term strategy is defined as ‘a high level plan to achieve one or more goals under conditions of uncertainty‘. A Regulatory Strategy created by KD&A specifically for your organisation...