Quality Management
Medical device manufacturers are required by law to establish and maintain a Quality Management System (QMS), among many other requirements. For all medical devices, with the exception of devices with comparatively low risk potential (Class I), the manufacturer is required to have its QMS audited and certified by a notified body before placing it on the market.
As a manufacturer, your quality management system must comply with the respective national requirements (for example ISO 13485, MDSAP or 21 CFR part 820 (US-FDA)).
WE ARE HAPPY TO HELP YOU
– Implement the requirements for the quality management system
– Create process instructions that really fit your company and are applicable
– Implement the requirements of other countries in such a way that your system remains clear and simple.
– During audits (internal or by notified bodies/authorities)
Quality Management
Medical device manufacturers are required by law to establish and maintain a Quality Management System (QMS), among many other requirements. For all medical devices, with the exception of devices with comparatively low risk potential (Class I), the manufacturer is required to have its QMS audited and certified by a notified body before placing it on the market.
As a manufacturer, your quality management system must comply with the respective national requirements (for example ISO 13485, MDSAP or 21 CFR part 820 (US-FDA)).
WE ARE HAPPY TO HELP YOU
– Implement the requirements for the quality management system
– Create process instructions that really fit your company and are applicable
– Implement the requirements of other countries in such a way that your system remains clear and simple.
– During audits (internal or by notified bodies/authorities)