Global Interest News - Aug 2019
IMDRF: Guidance drafted on regulatory pathways for personalised medical devices IMDRF: Comments solicited on terminologies for...
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ARQon
Jun 28, 20191 min read
Global Interest News - Jun 2019
EU/US: Cooperation on development of UDI database specifications IMDRF: Assembly and technical guide for IMDRF ToC submissions IMDRF:...
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ARQon
Jun 28, 20191 min read
South Korea's MFDS Revision of Medical Device Manufacturing and Quality Control Standards
On 25 March 2019, South Korea's Ministry of Food and Drug Safety (MFDS) published a notification titled "Professional revision of medical...
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ARQon
Mar 29, 20191 min read
Global Interest News - Mar 2019
IMDRF: Optimising standards; Essential Principles; personalised medical devices ISO: Third edition of ISO 14155 on clinical...
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ARQon
Nov 20, 20181 min read
US FDA releases Modifications to the List of Recognized Standards
The US FDA announced a publication containing modifications made to the list of standards FDA recognizes for use in premarket review (FDA...
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ARQon
Nov 9, 20181 min read
Korea MFDS Plans for Harmonization with Latest ISO 13485 & MDSAP
Korea MFDS' entry into the International Medical Device Regulators Forum (IMDRF), together with their intention to harmonize with the...
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ARQon
Sep 4, 20181 min read
Global Interest News - Aug/Sep 2018
IMDRF: Consultations being held on guidance documents concerning adverse event reporting, labelling and UDI ISO: Latest revisions of ISO...
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ARQon
May 24, 20181 min read
US QSR Revision Plan For Harmonization To ISO 13485
“FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing...
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ARQon
May 23, 20181 min read
Global Interest News - May 2018
IMDRF: Final guidance documents published IMDRF: Consultation held on ‘Essential Principles of Safety and Performance’ of medical devices...
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ARQon
Feb 2, 20181 min read
Global Interest News - February 2018
IMDRF: Essential Principles of safety and performance of medical devices and IVDs Click here for the full article on Global Regulatory...
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ARQon
Jan 1, 20181 min read
Global Interest News - December 2017
IMDRF: Personalised medicine; final guidance documents; draft proposals on use of patient registry data ISO: New handbook on medical...
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