Regulatory Information

Qlicksmart's Regulatory Commitment

Qlicksmart is accredited to ISO 13485, the International Standard for Quality Management System for medical device companies. In particular, our quality system complies with:
•FDA 21 CFR Part 820
•EC Council Directive 93/42/EEC as amended by Directive 2007/47/EC
•Compliant with Medical Device Regulation (EU) 2017/745
•Australian Therapeutic Goods Act 1989, Australia Therapeutic Goods Amendment (Medical Devices) Act 2002, and Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009.
We also vigorously advocate legislative change to integrate staff safety audits into the current independent accreditation programs for hospitals in Australia, the United States, the United Kingdom, Europe, and Asia.

Qlicksmart's Certificates

EN ISO 13485:2016

Qlicksmart maintains a Quality Management System which is verified under EN ISO 13485: 2016

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EC Certificate

Qlicksmart's Scalpel Blade Removers (Class Is) fulfil Annex V of Council Directive 93/42/EEC concerning medical devices

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Frequently Asked Questions for Hospital Tenders

Qlicksmart Products' Regulatory Information

Declarations of Conformity


United States


Australia/New Zealand

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