Compliance frameworks, security audits, and quality certifications this company maintains.
Quality
FDA 21 CFR Part 820 (QSR)
CertifiedJohnson & Johnson MedTech's manufacturing facilities comply with FDA 21 CFR Part 820 Quality System Regulations, ensuring that medical devices including DePuy Synthes orthopedic implants, Ethicon surgical instruments, and Shockwave IVL systems are manufactured, tested, and documented according to FDA good manufacturing practice requirements.
J&J MedTech holds ISO 13485 medical device quality management system certification across its global manufacturing network, providing an internationally recognized framework for the design, development, and production of surgical robots (Ottava), cardiovascular devices (Impella), and orthopedic implants (DePuy Synthes) sold in 100+ countries.
Quality
GMP (21 CFR Parts 210/211)
CertifiedJohnson & Johnson's Innovative Medicine manufacturing facilities comply with FDA Current Good Manufacturing Practice regulations for pharmaceutical production, ensuring that oncology drugs (Darzalex, Erleada), immunology biologics (Tremfya, Stelara), and CNS treatments (Spravato) are manufactured with validated processes and stringent quality controls.
Quality
ICH Q10 Pharmaceutical Quality System
CompliantJ&J Innovative Medicine's global pharmaceutical operations comply with ICH Q10 guidelines for pharmaceutical quality system management, integrating risk management, knowledge management, and continual improvement processes across its active pharmaceutical ingredient and finished drug product manufacturing operations for biologics and small molecule drugs.
Regulatory
EU MDR (2017/745)
CompliantJ&J MedTech has completed the EU Medical Device Regulation (MDR 2017/745) conformity assessment process for its core device portfolio — including DePuy Synthes implants, Ethicon surgical stapling systems, and Shockwave IVL catheters — maintaining CE marking under the stricter post-market surveillance and clinical evidence requirements of the EU MDR framework.
Johnson & Johnson's US pharmaceutical and medical device operations comply with HIPAA Privacy and Security Rules governing the handling of protected health information collected through patient support programs, Janssen CarePath hub services, and clinical trial data systems supporting J&J's Innovative Medicine drug commercialization activities.
Environmental
ISO 14001 Environmental Management
CertifiedJohnson & Johnson maintains ISO 14001 environmental management system certification across its global manufacturing operations, supporting J&J's commitment to achieve carbon neutrality by 2030 and net-zero carbon across its value chain by 2045 — including pharmaceutical manufacturing facilities and MedTech device production plants worldwide.
J&J's digital health platforms — including Janssen CarePath patient support portals, MedTech device connectivity platforms, and clinical trial data management systems — maintain SOC 2 Type II certification for security, availability, and confidentiality controls governing patient health data processed through J&J's healthcare technology infrastructure.
Regulatory
FCPA Compliance Program
CompliantJohnson & Johnson maintains a comprehensive Foreign Corrupt Practices Act compliance program governing its global pharmaceutical and medical device commercial operations in 150+ countries, including anti-bribery training for sales and marketing staff, third-party due diligence for distributors and healthcare professional interactions, and DOJ/SEC compliance monitoring requirements.
Safety
IEC 62304 Medical Device Software
CompliantJ&J MedTech's software-embedded medical devices — including Ottava surgical robotics, Impella heart pump controllers, and Shockwave IVL console software — comply with IEC 62304 medical device software lifecycle process standards, ensuring safety-classified software is designed, tested, and maintained according to FDA and international regulatory requirements for safety-critical medical software.