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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 ISO 13485:2003 and EN ISO 13485:2012 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 and the regulatory requirements specified in 21 CFR and MDD93/42/EEC.

MD 75473 QMS ISO 13485

CE 75472

FM 540981

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