The European Medical Device Regulation (MDR) is a new set of regulations (effective May 2021) that governs the production and distribution of medical devices in Europe. Compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.
While many of these changes are good—including digitizing IFU and reducing our collective carbon footprint—there are unintended consequences that put an undue burden on device companies of all sizes. By regulation, all medical device companies doing business in Europe must have their medical device documentation digitally available in a secure, validated environment
Shedpaper can help you achieve and maintain documentation compliance, so you can focus on what you do best. We’ve leveraged our background in data management, engineering, operations management, medical device manufacturing, and MDR remediation to create a validated, secure, and streamlined process for managing your digital IFU. With Shedpaper, your records are secure, and your revision changes are traceable and auditable. You have our guarantee.
- Designed to complement your change control system
- An accessible solution that meets pre-defined medical device directives for hardware, software, and error management (U.S. FDA 21CFRPart 11 & ISO encryption and security requirements)
- A relational database that enables your company and your external auditors to easily store and retrieve documentation including IFU, periodic safety update reports, and controlled information
- An immediate cost savings over paper
- Functions independently of existing IT
- Usability tested globally
- NOT a file share system with single point of failure
- Engineered for maximum uptime
