Quality Management
for Medical Devices
Consulting and Support
Quality Management
Quality Management System (QMS)
for Medical Devices
A quality management system (QMS) is defined as a formalized system that documents:
• processes;
• procedures;
• responsibility.
All this is aimed at achieving 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 consulting and assistance on quality management systems for medical device companies throughout Europe and the United Kingdom.
Our services on quality management systems (QMS)
for Medical Devices
The services provided include, but are not limited to:
- implementation, audit, and improvement of ISO 9001 and 13485 quality management systems and their updating;
- implementation, audit, and improvement of ISO 22716, BRC, and IFS standards and their updating;
- prepare companies for certification audits or resolve issues and non-conformities following an audit/inspection;
- supplier audits;
- provide specialist assistance for manufacturers of in vitro diagnostics (IVD).
Focus on ISO 13485
How much does it cost to set up a quality management system that complies with ISO 13485?
The costs of implementing an ISO 13485-compliant system depend on factors such as:
- size of the organization, number of offices and branches, number of employees;
- scope of the quality management system; (e.g., development, production, sales, support, etc.)
- other quality management systems, such as ISO 9001;
- management commitment and employee involvement.
How long does it take to set up a quality management system that complies with ISO 13485?
Generally, consulting services to support companies in setting up a quality system can vary from 8 to 20 days, over a period of at least 6 months to obtain certification.
Do you need to set up a
quality management system?
Fill out the form with your request.
We will contact you as soon as possible.
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