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MILLENSYS Quality Certifications and Approvals
MILLENSYS is a joint stock company and is a leader in medical imaging and healthcare solutions. MILLENSYS Solutions are medically certified with the most important quality patient safety certificates like “ISO 13485:2003, CE-Mark and FDA”.
MILLENSYS is contentiously improving and expanding its product line by introducing innovative ideas to complete its product line for the medical imaging and IT market.
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ISO 13485:2003
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.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.
If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.
 Download MILLENSYS ISO Certrificate 
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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.
Download MILLENSYS CE Certrificate
Download MILLENSYS CE Decleration |
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FDA 510(K) Approval
Under section 510(k) of the Act, a person who intends to introduce a device into commercial distribution is required to submit a premarket 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 premarket 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.
Download FDA 510K Approval |
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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 im plement, and enable care providers to use information more effectively.
Download IHE Connectathon Results
Download IHE statement |
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