After a series of delays and false starts, EMA is now progressing its ISO IDMP agenda with firm intent. The first implementation guide is out now for consultation, to be followed by a second actionable version by next year. Life sciences companies targeting Europe will have a year to comply with all the measures—but this will be a lot of work.
Using automated technologies can help medtech manufacturers de-risk their supply chain, increase productivity and save costs.
This educational event will help medtech manufacturers learn about one of the most complicated aspects of quality system requirements.
Trends that push boundaries and shake up medical device security.
Reduce risk and control your label, its design, and the data.
Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.
The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.
How manufacturing execution systems not only help with audits but also aid in production efficiency and faster product introduction.
As medical technological capabilities increase along with the proliferation of embedded systems and IoT, cybersecurity is becoming a very real risk for the medical industry. While securing the whole medical device industry may seem like an insurmountable task, the combination of education, regulation and technology is a good first step toward protecting our most critical infrastructure from attack.
Sharing more information with design partners on device function and its inherent risks can help guide better decisions during the product development process, and keep patients safer.