Regulations the world over are under intense scrutiny and almost everyone is undertaking reform. But what’s actually changing? A comparison of the major jurisdictions suggest less change than you might think.
Archives for October 2015
The first step of understanding the likely regulatory requirements is device classification. In all jurisdictions using the GHTF model of regulation, there are risk based classification rules, more or less identical to those first published in Annex IX of the European Medical Device Directive EC 93/42. Getting the classification right is vital. The level of […]
Brandwood Biomedical was delighted to support the TGA Sponsor training day held in Canberra on 15 October. The entire slide set of presentations is now available on line.
2105 in Baltimore. It’s going to be a busy few days with a great program of workshops and presentations as well as a very full exhibition. We will be at Booth number 363 – stop by and say hello – we would be delighted to catch up with old friends and of course to meet some new ones.
Regulators around the world are ramping up expectations for clinical evaluation of medical devices – all devices – with tougher requirements for higher risk devices and especially implantables. So what’s involved in collecting the evidence and preparing a Clinical Evaluation Report?
There’s growing interest in modernisation of China’s use of international standards in medical device regulation. This is especially the case in ISO 10993 biocompatibility evaluation and 12 leading experts from ISO joined a full day workshop on Biological Evaluation of Medical devices in Guangzhou China.