Quality Assurance

CarieScan Ltd is committed to ensuring that all products and services meet strict quality standards and local regulatory requirements.

We design, develop and manufacture all products in compliance with Council Directive 93/42/EEC, BS EN ISO 13485:2003 and Code of Federal Regulations Title 21 Part 872 Subpart B.

Clinical Trials were conducted in accordance with BS EN ISO 14155: 2003 and ICH GCP.

Our Notified Body is SGS UK Ltd.

Approvals granted in the design and manufacture of the CarieScan PRO:

Approval

Definition
Code of Federal Regulations Title 21 Part 872 Subpart B 510(k) K090598
Health Canada Licence Licence No. 78292

FDA 21 CFR 820.30

Design Control Guidance for Medical Device Manufacturers.

BS EN ISO 13485:2003

Medical Devices – Quality Management Systems, EU & Canada.

BS EN ISO 9001:2000

Quality Management System – Requirements.

IEC/UL 60601-1

Medical Electrical Equipment, incl national variations for EU & US.

CSA-C22.2 No601.1-M90 Part 1

Medical Electrical Equipment, incl national variations for Canada.

EN 60601-1-2:2001

EMC: unintentional transmitters.

FCC 47CFR Part 15

Radio Frequency Devices.

EN 980:2003

Medical Device Symbols for Labeling.

BS EN ISO 14971:2000

Risk Management for Medical Devices.

IEC 62304: 2006

Life Cycle Processes.

ISO 10993-1:2003

Biological Examination of Medical Devices.

EN 1041:1998

Information Supplied by the Manufacturer.

ISTA 1a

Transit Test.


Approvals granted in the design and manufacture of CarieScan PRO Sensors:

Approval

Definition
Code of Federal Regulations Title 21 Part 872 Subpart B 510(k) K090598
Health Canada Licence Licence No. 78292

FDA 21 CFR 820.30

Design Control Guidance for Medical Device Manufacturers.

BS EN ISO 13485:2003

Medical Devices – Quality Management Systems, EU & Canada.

BS EN ISO 9001:2000

Quality Management System – Requirements.

EN 980:2003

Graphical symbols for use in the labeling of medical devices.

ISO 11135-1

Sterilization of Health Care Products-Ethylene Oxide Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices.

ISO 10993-7

Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Residual Levels.

ISO 11737-1

Sterilization of Medical Devices, Microbiological Methods Part 1: Determination of a population of micro-organisms on products.

ISO 11607-1

Packaging for Terminally Sterilized Medical Devices

ASTM F1980

Accelerated Aging of Sterile Medical Device Packages.

ASTM D3078-20

Determination of leaks in flexible packaging by bubble emission.

ISO 2859-4:2002

Sampling procedures for inspection by attributes.

ISO 14644-1 Part 1

Cleanrooms and associated controlled environments.

BS 5295:1989

Specification for monitoring cleanrooms and clean air devices.