Electronic instructions for use (eIFU) unlock a range of benefits for medical device and in vitro diagnostics (IVD) manufacturers, from reducing costs to increasing flexibility. But any data managed online must be protected, and eIFU systems are no exception.
Protect against threats
"The threat spectrum is ever-evolving, and the baseline increases each year," explains Dimitri Jordens, eIFU and information security manager. Regulations are there to protect the end-user, to ensure that the information provided is correct and available.
Many regulations require protection against hardware and software intrusion. ISO27001 governs how people interact with software inside a company. IFUcare's ISO27001 qualification puts it in the best position to assure information security.
Choose your strategy
"In the last five to six years, we have seen people moving away from custom solutions," says Jordens. "The level of complexity about security is becoming more stringent." Choosing the right partner takes away challenges from manufacturers.
The software development life cycle (SDLC) enables manufacturers to ensure security and increase control. IFUcare establishes the SDLC on behalf of customers for the highest level of compliance.
Know the right partner
IFUcare completes quarterly monitoring against the top ten threats. "We want security of such a high level that the likeliness or impact of a breach is reduced as much as possible." IFUcare holds both ISO13485 and ISO27001 qualifications.
