Quality Management Systems
Quality Management Systems
for Medical Devices
Quality Management Systems
for Medical Devices
Consulting and Assistance
Quality Management System (QMS) for Medical Devices
Quality Management System (QMS) for Medical Devices
A quality management system (QMS) is defined as a formalized system that documents:
- processes;
- procedures;
- responsibilities.
All to achieve policies and objectives that define the quality of a medical device.
A QMS helps coordinate and direct an organization's activities to meet regulatory and customer requirements
and improve its effectiveness and efficiency on an ongoing basis.
We provide QMS consulting and support for medical device companies throughout Europe and the UK.
Our services on quality management systems (QMS)
for Medical Devices
Our services on quality management systems (QMS)
for Medical Devices
Services provided include, but are not limited to:
- implementation, audit and improvement of ISO 9001 and 13485 quality management systems and their updates;
- implementation, audit and improvement of ISO 22716, BRC and IFS standards and their updates;
- prepare companies for certification audits or resolve issues and non-conformities following an audit/inspection;
- supplier Audits;
- provide specialized support for in vitro diagnostic (IVD) manufacturers.
Focus on ISO 13485:
Focus on ISO 13485:
How much does it cost to set up an ISO 13485-compliant quality management system?
The costs of implementing an ISO 13485-compliant system
depend on factors such as:
- dimensioni dell'organizzazione, numero di sedi e filiali, numero di dipendenti;
- ambito del sistema di gestione della qualità; (es. Sviluppo, produzione, vendita, supporto, ecc.)
- altri sistemi di gestione della qualità, ad esempio ISO 9001;
- impegno di gestione e coinvolgimento dei dipendenti;
How long does it take to set up an ISO 13485-compliant quality management system?
Typically, the estimated time is between 8 and 20 days.
Do you need to set up a quality management system? We're here to help!
Do you need to set up a quality management system? We're here to help!
We want to know your needs exactly so that we can provide the perfect solution. Let us know what you want and we’ll do our best to help.