Swissmedic: Reporting Serious Events for Medical Devices & IVDs
Swissmedic recently unveiled an insightful video that underscores the critical nature of reporting serious…
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Showing 244–252 of 635
Swiss Economic Operator Vigilance Requirements Under MedDO
With the establishment of…
FDA Drafts Guidance for Dental Bone Grafting Studies
The FDA has provided draft guidance concerning its recommendations related to animal studies used to support premarket notification (510(k)) submissions…
EU Council: New Rules to Prevent Medical Device Shortages
The EU Council has adopted new rules to prevent medical device shortages and…
New Update to the MDCG 2022-4 Guidance Document
The Medical Device Coordination Group (MDCG) has released an update to the MDCG 2022-4 (Rev. 2)…
MHRA International Recognition for Medical Devices
The MHRA has issued a statement describing the draft policy detailing the intention of the UK to proceed with…
Medical Device Risk Management for Device Manufacturers
Like other types of therapeutic products, risk is…
Understanding TGA Application Audits for ARTG Inclusion
While not all applications for inclusion of a device on the Australian Register of Therapeutic Goods (ARTG) are subject…
MHRA Proposes Common Specifications for High-Risk IVD Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has proposed future amendments to the Medical Devices Regulations 2002 (MDR…
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