Quality Standards



CE MarkIVD


Certificate: Link

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 (98/79/EC), and that the device may be legally commercialized in the EU.
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BSI logoSCC logo


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The Canadian Medical Devices Conformity Assessment System (CMDCAS) implements Canadian regulations requiring medical devices to be designed and manufactured under a registered quality management system (QMS) such as the international standard ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes.
More information from the Standards Council of Canada



ISO 13485 logo


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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.
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ISO 9001 logo


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ISO 9001 is the internationally recognized Quality Management System (QMS) standard.
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EU logo


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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

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Objective Imaging Ltd

Unit 1, Quy Court
Colliers Lane
Stow cum Quy
Cambridge CB25 9AU
United Kingdom
Tel: +44 (1223) 813777

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Objective Imaging Inc

25707 Minnetonka Dr
Kansasville, WI 53139
USA
Tel: +1 (262) 514-2313
BSI Registered

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