SAI Global Product Certification offers a number of certification schemes tailored for medical devices. These certification services include:
CE Program – Medical Devices Directive 93/42/EEC
is offered to those selling their medical devices in the European Union. The Medical Devices Directive covers not only medical devices but also their accessories.
Medical Device means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
- investigation, replacement or modification of the anatomy or of a physiological process
- control of conception.
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
Accessory means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.
Second Party Inspections and Assessments are based on the requirements of our clients, as opposed to a specific Standard. The compliance can be to a process or to a product, against an agreed specification. The purpose of a second party inspection and assessment is to provide the customer with objective evidence of compliance to a specification, as agreed between customer and supplier.
Laboratory Recognition is offered to those laboratories which do not carry ILAC member accreditation for a specific standard and/or test method. These laboratories can be added to the SAI Global Recognised Laboratory Listing following an assessment of their test facilities to the specified standard and/or test method. The laboratory itself must also be able to demonstrate conformity to ISO/IEC 17025 in the test methods that will form the basis of the test report(s) supplied to SAI Global.