תוכנה לניהול תאימות למכשירים רפואיים ובריאות

Bringing a medical device to market in the EU under the Medical Device Regulation (MDR 2017/745) requires a Technical File so comprehensive that many SME manufacturers describe it as the single largest operational investment they make outside of R&D. The Technical File must contain clinical evidence, biocompatibility data, risk management assets (ISO 14971), design verification and validation records, labelling, IFU, and post-market surveillance plans — all reviewed and maintained to Notified Body standards. In the US, FDA 510(k) clearance demands predicate device comparisons, performance testing, and biocompatibility evidence in a different format and structure.

Device families — groups of devices sharing a common platform but differing in size, configuration, or intended use — multiply the asset-management challenge. Each variant requires its own clinical evaluation, risk analysis, and labelling, yet shares underlying design assets, biocompatibility data, and manufacturing process validation with sibling devices. Managing this shared-but-distinct asset structure in general-purpose file storage systems leads to version conflicts, orphaned assets, and audit findings that delay market clearance.

Sustalium מארגנת תאימות של מכשירים רפואיים סביב מבנה משפחת המכשירים. Shared assets — design history files, manufacturing process validation, sterilisation evidence — lives at the family level, while variant-specific records (clinical evaluations, labelling, UDI data) live at the device level. רישומי מערכת האיכות ISO 13485 משתלבים לצד הגשות רגולטוריות ולא בממגורות ניהול איכות נפרדות. Post-market surveillance data — complaint trends, vigilance reports, PMCF study results — feeds back into the risk management file as living evidence. When a Notified Body schedules an unannounced audit or the FDA requests pre-market assets, the Technical File is assembled from current, linked records rather than reconstructed from archived folders.