Iso 13485

ISO standard

mentions

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Recent News17

ifucare.io·há 7 meses

Summary of Commission Implementing Regulation (EU) 2025/1234

Learn how Commission Implementing Regulation (EU) 2025/1234 broadens electronic Instructions for Use (eIFUs) for professional medical devices, the compliance steps required, and how IFUcare can help.

ifucare.io·há 10 meses

MedTech Europe eIFU Adoption for Lay-Use Devices | IFUcare

MedTech Europe has taken another significant step in its push for digital healthcare, publishing new guidance on eIFU for near-patient tests following its position paper on lay-use devices.

ifucare.io·há mais de 1 ano

eIFU Compliance Starts with Validation | IFUcare

Learn why system validation is the foundation of eIFU compliance and how to ensure your electronic Instructions for Use platform meets regulatory requirements under EU MDR and IVDR.

ifucare.io·há cerca de 2 anos

Post-Market Surveillance with eIFU | IFUcare

Post-market surveillance has become more critical than ever. Learn how eIFU can revolutionize PMS in the IVD and MD industry.

ifucare.io·há mais de 2 anos

Full-Service eIFU Solution.Powered by Regulatory Experts.

Regulatory requirements, integration and validation are at the core of IFUcare's design. In-house regulatory, quality, support & development specialists End-to-end validation built into the platform

ifucare.io·há mais de 2 anos

Pioneer in the field of eIFU

A standalone eIFU solution, backed by regulatory experts in IVD and Medical Devices IFUcare was founded in 2008 by regulatory experts specializing in Quality Systems and Regulatory Affairs for the IV

ifucare.io·há mais de 2 anos

One platform. Full compliance.

Everything you need for compliant eIFU distribution, built by regulatory experts Our platform is EU/FDA regulation compliant and can be configured to suit your needs. Distinct groups of documents can

ifucare.io·há mais de 2 anos

Benefits of IFUcare

Discover why leading medical device manufacturers choose IFUcare for their eIFU needs IFUcare enables medical device (MD) and in vitro diagnostic (IVD) manufacturers to leave paper instructions for u

Related Entities

1Medical Device8×
2Regulatory Compliance8×
3Eifu8×
4Electronic Instructions For Use8×
5Eu Mdr8×
6Eu Ivdr8×
7Ivd6×
8Fda6×

Iso 13485 — Entidade | Buobe