Curtiss-Wright Industrial Division’s range of mobility-vehicle control systems are designed, produced and supported in accordance with global approvals. Applicable documents can be downloaded from this page.
FDA (Food & Drug Administration)
Master Files (MAFs) are held by the FDA for the S-Drive, newVSI, VR2 (includes nVR2 and nVR2 BLDC) and R-net control systems. When a mobility vehicle is submitted for 510(k) approval, the appropriate MAF can be referenced with a Letter of Authorization from Curtiss-Wright.
Medical Device Regulation
The European Union’s Medical Device Regulation’s Date of Application is May 26th 2021, when it will replace the Medical Device Directive (93/42/EEC).
DEFINITION OF ABBREVIATIONS
As suppliers of components to Medical Devices, Curtiss-Wright are well-positioned to support our OEM customers and their supply chains in meeting the requirements of the MDR.
The basis of this support is to supply a Manufacturer’s Declaration for each product type, which can be included in the overall documentation for the Medical Device to which the control system is fitted. This approach is necessary as, under the definition provided in the MDR, a control system is a part with no function of its own meaning it is a component of a Medical Device. Therefore, a Declaration of Conformity or CE Mark is not appropriate until the component is incorporated into the final product, i.e. a mobility vehicle.
As such, MDs are issued to aid the installation of the component (control system) into the finished product (mobility vehicle).
Curtiss-Wright can supply MDs for: S-Drive, newVSI, (n)VR2 and R-net.
NOTE ON MDR ANNEX 1
As of the DoA of the MDR, it will not state any mobility-vehicle-specific harmonized (cited in the OJEU) standards. To mitigate this, all CW control systems will be designed to comply with the latest versions of:
Use the links below to view our MDR Declarations
Although TÜV certification is not a requirement of the MDR, it does give assurances a product is designed and manufactured to the highest standards.
TÜV certificates are available for: S-Drive, newVSI, (n)VR2 and R-net