Quality Assurance

Novoxel™ is committed to Quality and to consistently maintain the level of operations required to meet customer requirements.

Novoxel™ is certified and operates a Quality Management system which complies with the requirements of ISO 13485:2016 for design manufacture and customer support of thermo- mechanical ablation systems in dermatology.

Regulation

Novoxel™ is regulated and certified under EC Certificate- CE643960, Full Quality Assurance System Directive 93/42/EEC on medical Devices, Annex II excluding section 4.
Novoxel™ family of products comply with additional local regulations in the countries where they are marketed.

Certificates

• ISO 13485:2016 for design manufacture and customer support of thermo- mechanical ablation systems in dermatology.
• EC Certificate according to the medical Device directive
• Australia: Therapeutic Goods (medical Devices) Regulations, 2002, Schedule 3 Part 1(excluding Part 1.6) – Full Quality Assurance Procedure

Download Novoxel Ltd ISO

Download Novoxel GmbH ISO

Download Final Certificate - CE 643960 Novoxel Ltd

Download Final Certificate - CE 655935 Novoxel GmbH

Skip to content