Everything You Need to Jump-start Your ISO 13485 Project
As soon as you install the software most of your new quality system is automatically implemented. You can immediately start editing and controlling your documents, initiate corrective actions, process customer complaints, and so forth. The only work left is to customize the manual and procedures, and start running the system.
A Platform for Part 11 Paperless Management of Your Quality System
After you implement (and certify) your ISO 13485 system, the ISOXpress software will continue serving you as a platform for paperless document control and day-to-day management of your quality system. ISOXpress Professional edition features electronic signatures and fully complies with Part 11.
MDR/Vigilance and CAPA system compliant with 21 CFR 803 and MedDev 2.12.1
ISOXpress software includes Complaints, NC Product and CAPA modules compliant with FDA Medical Device Reporting (21 CFR 803), Euripean Medical Device Vigilance (MEDDEV 2.12.1), as well as Canadaian and Australian MD Vigilance requirements.
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