digital MDR compliance
on this, so
have to.
New changes require your documentation to be hosted in a secure, encrypted, and validated environment. Here on planet earth, this is simply not possible for most companies. Shedpaper ensures you can meet these requirements, offering better uptime better than cloud-based services and around-the-clock monitoring.
Conformance with the latest European Medical Device Regulation (MDR) is a significant business challenge that must be overcome in order to enjoy continued access to the EU market. This includes accessible, editable, change-controlled instructions for use (IFU), periodic safety update reports (PSUR), and summaries of safety and clinical performance documentation (SSCP). Lions and tigers and bears, oh my. Is your head spinning yet?
99.99% uptime
24/7 monitoring
100% no-brainer
Have you read US FDA 21CFRPart 11, ISO 14971: 2019, and EU 2017/745? Not your idea of beach reading? Don’t worry, we love this stuff. Let us handle your information and security management. No IT integration required.
Toto, we’re not in Kansas anymore. The new regulations for digital IFU require software validation, audit trails, predetermined criteria for the requirements, and independent testing documentation. Let us worry about the software, so you can get back to the science.
Rolling out changes to your IFU … in 10 languages? Need an audit trail of edits? Shedpaper provides you with on-demand, traceable, auditable document change control records. Our system is designed to easily supplement and integrate with your existing change control procedures.
The shift to electronic documentation is a good thing. At Shedpaper, we believe in waste reduction so much we named our company after it. We also made sure our services are less costly than printing paper IFU or creating a validated secure encrypted system on your own. Everyone wins.
consulting services
Since we’re here, go ahead and ask for help with periodic safety update reports (PSUR), MDR remediation, and more.
