MILLENSYS Quality Certificates

MILLENSYS and its products are certified with the multiple quality certificates e.g. “ISO 13485:2003, CE-Mark, FDA and IHE”.

ISO 13485

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

CE Mark

MILLENSYS is a certified Medical Device Directive 93 / 42 / EEC company that shall apply to medical devices and their accessories.

The fundamental requirements of the directive contain the general safety and efficiency requirements and special provisions with regard to the chemical, physical and biological properties, the risks of infection and microbial contamination, measuring properties, environmental properties, protection against radiation, mechanical, electrical and thermal risks. A for most products mandatory user's manual must inform the consumers about the properties and a safe way to use the product.

FDA 510(K)

Under section 510(k) of the Act, a person who intends to introduce a device into commercial distribution is required to submit a pre market notification, or 510(k), to FDA at least 90 days before commercial distribution is to begin. Section 513(i) of the Act states that FDA may issue an order of substantial equivalence only upon making a determination that the device to be introduced into commercial distribution is as safe and effective as a legally marketed device. Under 21 CFR 807.87, FDA established the content requirements for pre market notifications to be submitted by device manufacturers in support of the substantial equivalence decision. FDA has, however, discretion in the type of information it deems necessary to meet those content requirements. For example, to allocate review resources more effectively to the highest risk devices, FDA developed a tiering system based on the complexity and the level of risk posed by medical devices. Under this system, the substantial equivalence determination for low risk devices is based primarily on descriptive information and a labeling review, while the decision for higher risk devices relies on performance data.

IHE

IHE is an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 to address specific clinical need in support of optimal patient care. Systems developed in accordance with IHE communicate with one another better, are easier to implement, and enable care providers to use information more effectively.