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How pharmaceutical manufacturers can guarantee a seamless eIFU implementation
Electronic instructions for use (eIFUs) can offer major savings for manufacturers. Each implementation comes with unique risks and requirements that need to be carefully considered
The power of eIFU in a product recall process
Product recalls are a fact of life for Medical Device manufacturers – but they can also be a headache. Fortunately the advent of electronic Instructions for Use (eIFUs) is helping to ease the pain
Privacy and compliance in the medical industry: how firms can walk the tightrope
Recent changes in eIFU regulations have changed the way medical device firms operate. Utilising the power of eIFU innovations can help them adapt
The six crucial advantages of Software as a Service for eIFU
Software as a service – SaaS – has taken software development by storm thanks to its unparalleled flexibility and responsiveness. Medical device manufacturers and other eIFU users are reaping the rewards
e-IFU requirements translated for implantable medical devices
After the European Commission published the Commission Implementing Regulation (EU) 2021/2226 on 14 December 2021 – laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council with regards to electronic instructions for use of medical devices, replacing the Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices, a new era began.
IFUcare: its history, evolution of eIFU regulations and the road ahead
IFUcare is Europe’s leading companies when it comes to providing firms with IFU and eIFU support. The company’s growth since 2007 provides an insight into how the IVD and MD world is evolving
eIFUs: why electronic instructions are just part of the package
Many manufacturers have already started to enjoy the benefits of eIFU for Medical Device (MD) and In Vitro Diagnostic (IVD) products. But the benefits extend far beyond electronic instructions – offering wide-ranging opportunities in other essential business services for both existing users and those yet to take the plunge
A guide to the eIFU transition
Administrative and logistical hurdles around the switch from paper to eIFU can be daunting for manufacturers. Choosing the right partner helps tackle the challenges and maximise the rewards