South Korean MFDS Plans Greater Alignment of Quality Requirements with ISO 13485:2016

South Korea – South Korean MFDS Plans Greater Alignment of Quality Requirements with ISO...

EMERGO SUMMARY OF KEY POINTS: South Korea’s MFDS to harmonize Korea Good Manufacturing Practice (KGMP) quality system regulations to ISO 13485:2016. Aligning KGMP to...
EU Advances SPC Waiver Proposal

Europe – MDCG WORKING GROUP : Notified bodies, UDI, …

MDCG Working Group 1: Notified Bodies Oversight (NBO) - Terms of reference MDCG Working Group 2: Standards - Terms of reference MDCG Working Group 3: Clinical...
Device Firms to Inform New FDA Framework on Servicing

USA – Device Firms to Inform New FDA Framework on Servicing

Following a decision against extending regulatory requirements to third-party device servicers, the US Food and Drug Administration (FDA) is seeking feedback to inform upcoming...
UDI: 5 Opportunities You May Not Have Considered

USA – UDI: 5 Opportunities You May Not Have Considered

It may only be three letters, but for some manufacturers, UDI is a four-letter word. There are others who see the regulation as an...
CDRH Launches New 510(k) Pilot Program for Certain Ophthalmic Devices

USA – CDRH Launches New 510(k) Pilot Program for Certain Ophthalmic Devices

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) launched a new voluntary 510(k) pilot program to develop and refine...
Australian manufacturing licences and overseas GMP certification

Australia – TGA Proposes Regulation on IVD Companion Diagnostics

Australia’s Therapeutic Goods Administration (TGA) issued a consultation paper on Tuesday to propose a new framework for the regulation of companion in vitro diagnostic (IVD) devices. The framework proposes...
Artificial Intelligence : the Future in Healthcare and Medical Device Manufacturing

International – Artificial Intelligence : the Future in Healthcare and Medical Device Manufacturing

Artificial Intelligence has progressed significantly in recent years, algorithms are now used to discover drugs and diagnose diseases. Engineers, designers and scientists are combining...
US FDA Modifies List of Recognized Standards for Medical Device Premarket Reviews

USA – FDA Modifies List of Recognized Standards for Medical Device Premarket Reviews

EMERGO SUMMARY OF KEY POINTS: US FDA has updated its list of Recognized Consensus Standards for use in medical device premarket submissions. FDA’s latest...
Publication de la norme ISO 11930:2019 sur l'évaluation de la protection antimicrobienne d'un produit cosmétique

International – Insights on Upcoming Revisions to ISO 13485

Following the new outcome meeting statement posted Monday by the management committee of the International Medical Device Regulators Forum (IMDRF), Focus obtained insights into upcoming revisions...
Novartis, Foundation Medicine collaborate on companion diagnostics

International – Novartis, Foundation Medicine collaborate on companion diagnostics

A company focused on next-generation sequencing-based diagnostics is partnering with a large Swiss drugmaker. Foundation Medicine, based in Cambridge, Massachusetts, said Wednesday that it had formed a...

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