Product cost tracking, warranty reserve accounting, and FDA compliance cost documentation for medical device manufacturers. Nexus handles the financial complexity of regulated device development and commercialization.
510(k) and PMA submissions, quality system maintenance, and post-market surveillance all create significant costs that must be tracked, documented, and in some cases capitalized. Without structured cost tracking, FDA compliance costs are invisible.
Medical devices are frequently sold on consignment at hospitals and surgical centers. Tracking consignment inventory at dozens of customer locations, recognizing revenue on usage, and reconciling physical counts requires specialized inventory management.
Device warranty obligations require forward-looking reserve estimates based on historical failure rates and repair costs. Reserves must be updated regularly and are subject to auditor scrutiny.
GAAP (ASC 450 — Contingencies, for warranty reserves)
IFRS (IAS 37 — Provisions)
FDA 21 CFR Part 820 (Quality System Regulation)
ISO 13485 (Medical Device Quality Management)
Consignment inventory
reconciled monthly without manual counts
Warranty reserves
calculated automatically from failure rate data
FDA audit
trail complete and accessible
See how Plurafi handles your industry's complexity