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Regulatory Affairs

Quality Assurance

Quality is the cornerstone of a responsible, ethical and committed company. Quality assurance forms a key part of the organisation reflecting in all areas in which Neoss operates. Neoss is approved to EN:13458:2003 and all staff are educated and informed about QA policies.

Neoss Quality System is based on 21 CFR, Part 820 Quality Systems Regulation and ISO 13485:2003 and the regulatory requirements specified in 21 CFR and MDD93/42/EEC as amended by 2007\47\EC (LVFS 2003:11).

MD 75473 QMS ISO 13485

CE 75472

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