QMS Requirements
Overview
A QMS is required for manufacturers of Class IIa, IIb, III, and implantable Class I devices under MedDO. ISO 13485:2016 is the applicable harmonised standard, universally required by EU notified bodies assessing Swiss market access applications.
ISO 13485 Scope
ISO 13485 covers: management responsibility; resource management; product realisation (design controls, purchasing, production, sterilisation, servicing); measurement, analysis, and improvement (internal audits, CAPA, complaint handling). The QMS scope must include all processes relevant to the devices being registered.
QMS Certification and Conformity Assessment
For Class IIa+ devices, the NB performs a QMS audit (MedDO Annex IX Chapter I): reviews QMS documentation; conducts on-site audit (including unannounced audits post-certification); issues a QMS certificate. The NB QMS audit goes beyond ISO 13485 — it also assesses MedDO-specific requirements.
QMS for Class I Devices
Not required for NB conformity assessment purposes, but strongly recommended as it: provides the framework for managing technical documentation; supports complaint handling and vigilance processes; is required for export to most other regulated markets (EU, USA, Japan, Australia).
Official Sources
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