FDA Issues Draft Guidance on Cybersecurity for Medical Devices
The Food and Drug Administration (FDA) has released a draft guidance proposing revisions to the “Cybersecurity in Medical Devices:…
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UK Government Takes Action to Address Bias in Medical Devices
The Department of Health and Social Care in the UK announced an action plan in response to an independent report…
MDCG Guidance on Clinical Investigation Plans
The Medical Device Coordination Group (MDCG) has published guidance on content for the Clinical Investigation Plans. What are the key…
Updated EU Harmonized Standards List for MDR and IVDR Published
On 6th March, the EU Commission issued two significant decisions, EU 2024/817 and EU 2024/815, focusing on updating the…
EU Commission’s Latest Medical Device Standards Update
On 6th March, the EU Commission published Decision EU 2024/817 and Decision EU 2024/815. These two decisions focused on updating…
EU Regulatory Importer: Legal Liabilities & Considerations
Manufacturers of Medical Devices and In Vitro Diagnostics (IVDs) located outside the European Union (EU) are required to appoint an…
Integrating Swiss MedDO and IvDO into your QMS
Despite the Swiss Medical Devices Ordinance 812.213 (MedDO) having entered into force on May 25, 2021, and In Vitro…
European Commission Proposes to Extend Deadlines for IVDs
The European Commission published a proposal to amend 2017/745 (MDR) and 2017/746 (IVDR) on January 23rd 2024…
IVD Incident Reporting: Regulatory Standards for Manufacturers
In the complex world of medical device and IVD manufacturing, adherence…
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