Medical Device Regulation (MDR) European Union (EU) 2017/745 Transition – What is required by the May 2020 deadline?
Some manufacturers who have existing medical device MDD certificates may not transition before May 2020 and retain their current MDR until expiry, however a significant change to t
Building Technical Documentation Effectively
Product development is an all consuming process, taking considerable time and effort. An important activity associated with product development is the building of Technical Documen
Technical Documentation: What is it all about?
Various changes have been made to the regulation of numerous types of medical devices by the TGA, including software-based medical devices, prescription spectacle lenses, medical d
Regulatory Strategy – Key to Success
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 or
