Despite Travel Bans, WFH or other Causes for limited RA Resources a novel Regulatory Tool allows to remain compliant under MDR in EuropePosted Mar 12, 2020
MedtechVault has released its virtual document & information exchange system that is equivalent to On-site Document Audits for fast and efficient supplier evaluation by legal manufacturers. While being evaluated, this smart digital solution allows the supplier to always be in full control over the documents under review by ways of maintaining confidentiality of sensitive information.
Another module released earlier by MedtechVault allows to make the Technical Documentation available to European Authorized Representatives (EAR), Notified Bodies and other Economic Operators. While the confidential content is highly protected, MedtechVault allows an easy-to-manage document update process for all accessing parties during a medical device’s life cycle. If desired, the parties are being informed through an automated process about those updates.