Heritage with regulatory milestones
Decades of FDA-cleared, ISO 13485-audited medical device programs serving hospitals, sleep clinics, and home-care networks.
Regulatory milestones
Resmed cleared early positive-airway-pressure family devices under FDA 21 CFR 807 for US market entry.
QMS certification before ISO 13485 was finalized in 2003.
Additional 510(k) clearances expanded connected therapy and interface families—verify each current K-number on the exact reference.
Full quality-system mode for EU market on applicable product lines.
Inspection readiness and CAPA discipline remain model- and site-specific; always request the current EIR context for your procurement file.
Technical documentation files re-aligned under MDR where CE marking applies.
Software Bill of Materials disclosure expanded across SaMD-relevant portfolios per FDA Premarket Guidance.
ISO 14971 risk management sits at the core of design controls for interfaces, platforms, and consumables.
Label claims stay tied to intended use, verification evidence, and post-market surveillance—not slogan language.
Installed platforms are planned for multi-year preventive maintenance, cushion replenishment, and spare-parts continuity.
Leadership lenses
Bring the care setting, candidate references, and destination market. We will route documentation without assuming one clearance covers every SKU.
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