Medical Device & Health Compliance Management Software

Bringing a medical device to market in the EU under the Medical Device Regulation (MDR 2017/745) requires Technical Documentation 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 documentation (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 documentation challenge. Each variant requires its own clinical evaluation, risk analysis, and labelling, yet shares underlying design documentation, biocompatibility data, and manufacturing process validation with sibling devices. Managing this shared-but-distinct documentation structure in general-purpose file storage systems leads to version conflicts, orphaned documents, and audit findings that delay market clearance.

Sustalium organises medical device compliance around the device family structure. Shared documentation — 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. ISO 13485 quality system records integrate alongside regulatory submissions rather than in separate quality management silos. 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 documentation, the Technical File is assembled from current, linked records rather than reconstructed from archived folders.