Intersurgical focuses exclusively on respiratory care, designing, manufacturing and supplying medical devices used from emergency care and hospitals to the home. With more than 40 years of expertise, its vertically integrated business spans airway management, anaesthesia, critical care and oxygen therapy, including the i-gel® supraglottic airway. The company’s management systems are certified to ISO 9001, ISO 13485 and ISO 14001 standards, reflecting its focus on medical-device quality and reducing environmental impact.
ISO 9001:2015 – Quality Management Systems
certification
ISO 13485:2016 – Medical Device Quality Management Systems
certification
ISO 14001:2015 – Environmental Management Systems
certification
MDSAP — Medical Device Single Audit Program
certification
FDA 21 CFR 820 – Quality System Regulation, USA
compliance_program
Medical Device Regulation (EU) 2017/745
compliance_program
Medical Devices Directive 93/42/EEC
compliance_program
Medical Device Regulations 2002, Great Britain
compliance_program
Instrumentation Industries, IncSince 1967, Instrumentation Industries, Inc. has manufactured respiratory-care and other medical components in Pittsburgh, including the adapters, connectors and emergency ventilation parts used in clinical settings. The company molds plastic and silicone and fabricates metal in-house, supporting OEM customers from prototypes through production with its own tooling, machining, engineering and assembly capabilities. Its products are made in the USA, and the facility is ISO 13485:2016 certified.BETHEL PARK, PA
Monaghan Medical CorporationMonaghan Medical Corporation is a Plattsburgh, New York manufacturer known for patient-oriented respiratory care devices and research-backed aerosol delivery. Its affiliated aerosol laboratory supports peer-reviewed testing and development for patients, caregivers, and pharmaceutical companies working in respiratory medicine worldwide. The company operates with ISO 13485 and ISO 14001:2015 certification.PLATTSBURGH, NY
Drive MedicalDrive Medical is a leading manufacturer of durable medical equipment with a complete line of life-enhancing products focused on innovation, functionality, and value. The company manufactures and supplies a wide range of respiratory therapy products and other medical equipment, serving customers in more than 100 countries.SOMERSET, PA
CircadianceFounded in 2006 near Pittsburgh by medical-device engineer David Groll, Circadiance develops and manufactures respiratory-care equipment and remote patient-monitoring systems. The company is best known for SleepWeaver, the first all-cloth positive-airway-pressure mask, and also supports infant and pediatric care through SmartMonitor and Synergy Cloud products. Circadiance is ISO 13485 certified and distributes its products internationally.EXPORT, PA