Compliance frameworks, security audits, and quality certifications this company maintains.
Baxter's medical device manufacturing sites, including its infusion pump and IV solution facilities, are certified to ISO 13485, the international quality management system standard for medical device design, production, and post-market surveillance.
Regulatory
FDA 21 CFR Part 820
CompliantBaxter's U.S. medical device operations comply with FDA Quality System Regulation (21 CFR Part 820), governing design controls, production processes, and complaint handling for its infusion pumps, smart beds, and patient monitoring equipment.
Regulatory
cGMP (21 CFR Parts 210/211)
CompliantBaxter's pharmaceutical manufacturing sites, including IV solution and premixed drug production facilities, operate under FDA current Good Manufacturing Practice regulations to ensure sterility, purity, and potency of parenteral drug products.
Baxter's connected care and patient monitoring platforms, including Welch Allyn Connex and CareAware, are designed to comply with HIPAA Privacy and Security Rules, protecting patient health information transmitted through hospital networks.
Baxter applies ISO 14971 risk management processes across its medical device portfolio — including the Spectrum IQ and Novum IQ infusion pump families — to systematically identify, evaluate, and control patient safety risks throughout the device lifecycle.
Baxter's medical device software development, including Dose Error Reduction Software (DERS) for its infusion pump platforms and CareAware clinical communications, follows IEC 62304 software lifecycle processes required for Class B and Class C medical device software.
Baxter has implemented energy management systems aligned with ISO 50001 at key manufacturing sites as part of its 2030 sustainability commitments to reduce energy intensity and greenhouse gas emissions across its global operations.
Regulatory
EU MDR (2017/745)
CompliantBaxter's medical devices sold in the European Union comply with the EU Medical Device Regulation (MDR 2017/745), including conformity assessment, clinical evidence requirements, and registration in the European EUDAMED database for infusion systems and patient monitoring products.
Baxter's electrically powered medical devices, including its Spectrum IQ infusion pumps, Novum IQ syringe pumps, and Hillrom-brand patient monitoring platforms, are designed and tested to meet IEC 60601-1 electrical safety and essential performance requirements.
Baxter's connected care software platforms, including CareAware and Voalte mobile communication systems, maintain SOC 2 Type II certification, demonstrating that security, availability, and confidentiality controls protecting hospital customer data meet independent audit standards.