Compliance frameworks, security audits, and quality certifications this company maintains.
Stryker's medical device manufacturing facilities globally maintain ISO 13485:2016 certification for quality management systems specific to medical devices, ensuring consistent design, manufacturing, and post-market surveillance for orthopedic implants, surgical equipment, and neurovascular devices.
Regulatory
FDA 21 CFR Part 820
CompliantStryker complies with FDA Quality System Regulation (21 CFR Part 820) for medical device manufacturing, governing design controls, corrective actions, and production processes across all US-based and FDA-registered Stryker manufacturing facilities.
Regulatory
EU MDR 2017/745
CompliantStryker has transitioned its European medical device portfolio to comply with EU Medical Device Regulation (MDR) 2017/745, including updated clinical evaluation reports, EUDAMED registration, and post-market clinical follow-up for orthopedic and neurovascular devices.
Stryker's digital health platforms including Vocera clinical communication software and MAKO robotic surgery data systems comply with HIPAA privacy and security requirements, protecting patient health information processed in hospital and surgical environments.
Stryker applies ISO 14971:2019 risk management processes throughout the design and development lifecycle of all medical devices, ensuring systematic hazard identification, risk evaluation, and risk control for orthopedic implants and surgical robotics.
Stryker's active medical electrical equipment including MAKO robotic surgery systems, surgical power tools, and patient monitoring devices comply with IEC 60601-1 safety standards governing electrical safety and essential performance for medical electrical equipment.
Stryker's Vocera clinical communication platform and MAKO SmartRobotics cloud systems are SOC 2 Type II certified, ensuring the security, availability, and confidentiality of patient care workflow data and robotic surgery performance data stored in Stryker's cloud infrastructure.
Stryker's total joint replacement and trauma implant products are tested and certified to ASTM F2033 and related ASTM standards governing mechanical performance, biocompatibility, and corrosion resistance for metallic orthopedic implant materials.
Environmental
ISO 14001:2015
CertifiedStryker maintains ISO 14001:2015 environmental management certification at major manufacturing facilities, supporting the company's sustainability goals including a commitment to achieving carbon neutrality across its own operations and reducing single-use surgical waste.
Regulatory
FCPA Compliance
CompliantStryker operates a comprehensive Foreign Corrupt Practices Act (FCPA) compliance program governing its global sales force and distribution partners, following the company's 2012 FCPA settlement and subsequent implementation of enhanced anti-bribery controls in international healthcare markets.