How to Transition from Paper IFU to eIFU
Transitioning from paper-based IFU (Instructions for Use) to electronic IFU medical device solutions is becoming a necessity for medical device manufacturers. With evolving regulatory requirements such as EU MDR electronic IFU guidelines and FDA compliance, shifting to ...
Medical Device Adverse Event Reporting Regulations: EU vs. US FDA
Regulatory authorities in both Europe and the United States require medical device companies to report on some adverse events (AEs) that occur during clinical investigations.
Compliance with the ISO 14155:2020 Good Clinical Practices (GCP) standard also requires medical...
Effective Clinical Overviews: Regulatory Submissions
The Clinical Overview is a pivotal component of the Common Technical Document (CTD) that provides a critical analysis of the clinical data supporting a marketing application. This whitepaper outlines its purpose and structure, highlighting the need for a clear interpret...
What Are eIFU Services
Electronic Instructions for Use (eIFU) services are revolutionizing the way medical device manufacturers provide product information to users. With regulatory bodies like the EU MDR and FDA encouraging digital transformation, eIFU ensures easy access to up-to-date infor...
MHRA Final Rules for Post-Market Surveillance
Medicines and Healthcare Products Regulatory Agency (MHRA) finalized the Post-Market Surveillance Statutory Instrument (PMS SI), which marks a pivotal change in the regulatory framework for medical device manufacturers. This legislation, officially named the Medical Dev...
