Development, production and certification of pneumatic and electronic control systems for ventilation, respiratory therapy and anesthesia.
AC Aircontrols GmbH
Kempen · Planegg · Munich · Dublin, Ohio (USA)New on Amplifa
About AC Aircontrols
AC Aircontrols is an internationally active development service provider, manufacturer and supplier for the medical device industry, headquartered in Kempen. The company develops pneumatic and electronic control systems for life-sustaining medical devices, including for ventilation, respiratory therapy, anesthesia, gas dosing and ventilation of neonates. Its range of services covers software, hardware and design, system development, documentation and testing, regulatory approval consulting for the EU and USA (MDR, FDA), regulatory hosting as legal manufacturer, series introduction (design transfer) as well as series production with final inspection and testing. Assembly of electronic and mechanical assemblies as well as complete devices is carried out with certified partner companies; final assembly and testing are performed in-house. Lot sizes range from 10 to 2,000 units per year. In addition, AC Aircontrols supports products throughout the entire life cycle, including supply chain management, and is the exclusive German distribution partner for miniature pneumatics of Clippard Instruments Laboratory (USA). The quality management system is certified to DIN EN ISO 13485 by TÜV Nord.
- Site
- Kempen
- Processes
- Development of pneumatic and electronic control systems for medical devices, Design (mechanical development), Hardware development, Software development / GUI programming, System development, Series introduction / design transfer (scale-up from prototype via pre-series to series production), Assembly of electronic or mechanical assemblies as well as complete devices, Manual and automated functional and system testing
- Materials
- Pneumatic control systems, Electronic control systems, Clippard miniature pneumatics
- Certificates
- DIN EN ISO 13485:2016 (incl. AC:2018, A11:2021), DIN EN ISO 13485 – Munich location, DIN EN ISO 13485 – Planegg location, ISO 13485, MDR QM certificate
- Industries
- Medical technology, Anesthesia, Intensive care and emergency medicine, Pediatrics/neonatology, Respiratory therapy/oxygen therapy, Bioresonance therapy
- 01
Development (software, hardware, design, system development)
- 02
Documentation and testing
- 03
Series introduction / design transfer
- 04
Supply chain management
- 05
Assembly of assemblies and complete devices
- 06
Final inspection and testing (manual and automated)
- 07
Packaging and shipping
- 08
Life-cycle management
Materials and Processes
Pneumatic control systems
Project planning, design and manufacture of assemblies for precise miniature pneumatics in medical devices.
Electronic control systems
Hardware and software for safety-critical applications in hospitals and emergency medicine.
Clippard miniature pneumatics
Distribution of miniature valves, cylinders, special valves and accessories as exclusive distribution partner of Clippard Instruments (USA).
Locations
Kempen
DEHeadquarter
- Lot size
- 10–2,000 units/year
Planegg
DEAssembly & Test (operating facility)
Munich
DESoftware development
Dublin, Ohio
USSubsidiary AC Aircontrols USA, LLC
Components and Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Development of pneumatic and electronic control systems for medical devicesEngineering | – | – | – | – | – |
| Design (mechanical development)Engineering | – | – | – | – | – |
| Hardware developmentEngineering | – | – | – | – | – |
| Software development / GUI programmingEngineering | – | – | – | – | – |
| System developmentEngineering | – | – | – | – | – |
| Series introduction / design transfer (scale-up from prototype via pre-series to series production)Engineering | – | – | – | – | – |
| Assembly of electronic or mechanical assemblies as well as complete devicesAssembly | – | – | – | 10 units per year – 2,000 units per year | – |
| Manual and automated functional and system testingTesting | – | – | – | – | – |
| Manufacture of special test instruments/test benches for incoming and outgoing inspectionTesting | – | – | – | – | – |
| Final inspection and distribution of products for bioresonance therapyTesting | – | – | – | – | – |
| Project planning, design and manufacture of assemblies for precise miniature pneumatics (incl.Assembly | – | – | – | – | – |
| Pneumatic drives for surgical instruments (development/manufacture)Assembly | – | – | – | – | – |
| Supply chain management (global sourcing, supplier qualification, logistics, warehousing)Engineering | – | – | – | – | – |
| Life-cycle management (updates, redesign, obsolete component management, spare parts stocking)Engineering | – | – | – | – | – |
| Approval consulting (EU/USA), regulatory hosting, quality management according to DIN EN ISO 13485Engineering | – | – | – | – | – |
| Distribution of miniature pneumatic valves, cylinders, special valves and accessories (ClippardAssembly | – | – | – | – | – |
| Product examples: APL valves, drive gas control units, suction systems, gas mixing systemsAssembly | – | – | – | – | – |
Additional services
Reference customers
Quality and Certification
The quality management system is certified to DIN EN ISO 13485:2016 (incl. AC:2018, A11:2021) by TÜV Nord, including the Planegg and Munich locations. Production is subject to continuous quality controls with calibrated test equipment as well as special, customer-specific test instruments and test benches.
| Evidence | Kempen | Planegg | Munich |
|---|---|---|---|
| ISO 13485 | |||
| MDR QM certificate |
History
More than 20 years of experience in the development, production and certification of innovative medical technology in the fields of ventilation, respiratory therapy and anesthesia
- 2026
Together with SmartCPAP, winner of the Give a Breath Challenge for non-invasive ventilators and oxygen concentrators.