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Hospitalar 2025
Schedule a meeting to learn more about how we can support you in getting to market faster.
US FDA Status of eSTAR: eSTAR Version 5.5 Released
Here’s what medical device manufacturers need to know about the electronic submission template and resource (eSTAR) that will be required for De Novos starting in October 2025.
EU Opens Consultation on Draft Legislation for Electronic IFUs
Here’s what medical device manufacturers need to know about the proposed legislation that the European Commission (EC) opened allowing electronic Instructions for Use (eIFU) for medical devices used by professional users.
UK Regulators Update Guidance on IVD Registrations with Expiring CE Certificates
Are you an in vitro diagnostic (IVD) device manufacturer registering IVDs in the UK? If so, see our article on the new guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA).