A single review program for medical devices?
During this year’s Bio-Utah Summit in November 2019, Dr. Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health (CDRH) spoke about the new initiatives and modernization of...
And so starts the MDR/Brexit fallout… First LRQA and now QS Zurich fall by the wayside
Breaking News: As of June 13th, Lloyds Register Quality Assurance (LRQA) withdrew from MDD and IVDD services (see the announcement here). It's official, the first notified body based in UK...
TGA will no longer send “friendly reminders” for Annual Reports.
In a communication on May 15th, TGA announced they will no longer be providing courtesy formal correspondence requesting annual reports from Australian Sponsors, and failing to provide annual reports may...
Japan renews its participation in MDSAP until 2020
Japan’s participation in MDSAP (Medical Device Standardized Audit Program) has been a contributing factor in the exponential update of MDSAP by multinational companies. Japan’s MHLW and PMDA has been opting...
The commercialization continuum: beyond product registrations
Your product is approved, now what? This is a question that can bring a painful realization to medical technology manufacturers and suppliers eagerly entering a new market. The appropriate preparation...
MDSAP Stakeholder Update (FDA, TGA, Health Canada, PMDA, ANVISA)
On Dec 5th, 2018 the representatives from US FDA, Brazil’s Anvisa, Japan’s PMDA, Australia’s TGA, and Health Canada met in Washington, DC with stakeholders from the medical device industry to...
Halfway there? Will the MDR/IVDR train arrive on time – and what about Brexit?
As the implementation journey for the EU MDR/IVDR passes the halfway point, we provide an update to the current state of play and the impact on our industry. Many, if...
