Let's talk global medical device + IVD regulatory services

39:25 | Aug 18th, 2020

This podcast will provide an update to our 2019 webinar on In Vitro Diagnostic products, as well as current situations in US, Australia and other key geographies. Hear from TJ Thiel on recent regulato...Show More

38:39 | Jul 14th, 2020

This webinar will provide an update to our 2019 webinar on Software as a Medical Device (SaMD) and Software in Medical Devices. Yervant Chijian will highlight recent regulatory changes as they apply t...Show More

28:48 | Jun 16th, 2020

As regulators around the world look more closely at the Clinical Evaluation Report in support of a device's safety and efficacy, we revisit the key aspects of discussion on which manufacturers and spo...Show More

20:26 | May 20th, 2020

The Australian Therapeutic Goods Administration recently implemented several new initiatives that enable sponsors to utilise regulatory approvals from other jurisdictions (e.g. USA, Canada, Europe) to...Show More

39:53 | Apr 9th, 2020

With disrupted supply chains, shortages of medicines, masks, ventilators and test kits, everyone wants the regulator's attention - right now, today. The good news is that pandemic planning has been a ...Show More

29:22 | Mar 18th, 2020

As the ISO Technical Committee 194 prepares to meet later this year, we look at the planned changes to the standards, the rising prominence of chemical characterisation and the efforts to eliminate an...Show More

21:38 | Feb 19th, 2020

With just a few months to go to the MDR transition deadline, manufacturers will be subject to a raft of new formal postmarket reporting requirements. And they all rely on active data collection. Inade...Show More

30:20 | Jan 22nd, 2020

Learn how Australia does faster drug approvals through shared evaluations and leveraging international approvals. How to minimise risks from the European MDR devices train wreck and the growing trend ...Show More