eBooks

Regulatory authorities around the world are moving toward electronic product information (ePI) built on FHIR®. But with so many acronyms, formats, and evolving requirements, it can be hard to keep up. That’s why we created FHIR ePI 101: A Beginner’s Guide to Electronic Labeling.

E-labeling is no longer on the horizon - it’s here. That’s why we created this playbook: a one-stop resource combining expert insights, survey data, and practical guidance for life sciences professionals.

Managing medical device labels presents a myriad of challenges for manufacturers, including ensuring compliance with ever-evolving regulatory standards, maintaining accuracy and consistency in label content, and optimizing label design for clarity and usability.

As devices become more critical to patient outcomes, regulators’ quality and safety expectations and associated controls are increasing. But how well prepared are suppliers? We recently commissioned independent research to find out.