Digital Pathology Solutions
Quality and Regulatory Certifications
Certificate: Glissando 20SL
Certificate: Glissando Desktop Scanner
CE Marking is required for all in vitro diagnostic (IVD) devices sold in Europe. CE Marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive 2017/746 and that the device may be legally commercialized in the EU. The Glissando Desktop Scanner (40X) and Glissando 20SL (40X) have met these requirements for CE IVD certification.
More information from BSI
Certificate: Link
ISO 13485 provides a foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
More information from BSI
Certificate: Link
ISO 9001 is the internationally recognized Quality Management System (QMS) standard.
More information from BSI
Certificate: Link
The Waste Electrical and Electronic Equipment Directive (WEEE) sets collection, recycling and recovery targets for all types of electrical goods.
The Restriction of Hazardous Substances Directive (RoHS) restricts the use of certain hazardous materials in the manufacture of various types of electronic and electrical equipment.
The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation ensures limitations in the use of chemical products, for environmental safety.
More information on WEEE
More information on RoHS
More information on REACH
