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
ISO 13485:2016 – Medical Device Quality Management Systems
ISO 14001:2015 – Environmental Management Systems
MDSAP — Medical Device Single Audit Program
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
EUMDR
Quality certification
UKCA
Quality certification
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
IDE GroupIDE Group is an entrepreneurial medical-technology partner that designs, engineers, manufactures and commercialises healthcare products and ventures. Its cross-disciplinary team works across the full journey from problem discovery to market launch, with particular depth in regulated medtech and more than 20 years of respiratory-device experience. With ISO 13485:2016-certified operations in Australia and the Netherlands, IDE has helped bring products such as Bayer’s MEDRAD Centargo CT Injector and its own OKO ophthalmic auto-injection system toward market.NEWTOWN SQUARE, PA