TGA Creates Guidance on Device Standards for Quality Management Systems

Australia – Australia Explores Adopting UDI System

Device companies were given a tight deadline on Monday to comment on a new proposal that would establish a unique device identification (UDI) system...
FDA Revises 1999 Draft Guidance on Population Pharmacokinetics

USA – FDA Looks to Improve UDI Data Quality With Relaxed Limits on Labelers’...

A recent US Food and Drug Administration (FDA) notice proposed reverting to a 7-day grace period to review, edit and correct records that medical...
TGA Pushes for Total Product Lifecycle Approach to Medical Device Cybersecurity

Australia – TGA Pushes for Total Product Lifecycle Approach to Medical Device Cybersecurity

New draft guidance from Australia’s Therapeutic Goods Administration (TGA) encouraged use of regulatory policies that span total product lifecycles (TPLC) to ensure medical device...
CDRH Drafts Guidance on Mouse Embryo Assays

USA – MDUFA Report Touts CDRH Efforts to Improve Medical Device Review Processes

Efforts at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) to improve the medical device review process under the Medical...
What Will 2019 Bring for Medtech?

USA – What Will 2019 Bring for Medtech?

Healthcare is definitely changing, evident from several developments in 2018. While payers and providers have been working for some time to improve healthcare quality...
Ireland's research center for medtech eyes animal testing facility

Ireland – Ireland’s research center for medtech eyes animal testing facility

Ireland’s research centre for medical devices is to consider developing a national animal testing lab, to trial medical implants on large animals. Cúram, the NUI...
Roche Diagnostics launches cervical cancer screening lab in India

India – Roche Diagnostics launches cervical cancer screening lab in India

Cancer Institute (WIA) launched a molecular lab for cervical cancer screening on Wednesday. Roche Diagnostics India that provides in-vitro diagnostics solutions launched its HPV (Human...
S. Korean devicemaker debuts AI-based diagnostics platform

South Korea – S. Korean devicemaker debuts AI-based diagnostics platform

JLK Inspection, a member company of the K-ICT Born2Global Centre, is introducing its latest AI-based medical image diagnosis system, the AIHuB, a cutting-edge all-in-one...
European Regulators Publish UDI Guidance |

Europe – European Regulators Publish UDI Guidance

The Basic UDI-DI is the key identifier of a device in Eudamed, on certificates and on the Declaration of Conformity. Multiple UDI-DIs can...
Medical Device QMS Harmonization: US Considers Aligning to ISO 13485

USA – Medical Device QMS Harmonization: US Considers Aligning to ISO 13485

US FDA is considering adoption of ISO 13485:2016 quality system requirements for medical device registrants. ISO 13485 would replace FDA Quality System Regulations...

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