Qualitätsmanagement
MEDTECH360 will advise you or work with you to develop an applicable and suitable QM system for your company. This means that you and your employees learn how to work with it right from the start.
Our offer
- Support with the introduction and implementation of a QM system in accordance with
- EN 13485:2021
- Regulation (EU) 2017/745 (MDR)
- US 21CFR820 (QSR)
- GAP-Analysis
- Performance of 1st and 2nd party audits (internal and supplier)
- Performance of internal audits according to EN ISO 13485:2016
- Supplier selection and qualification according to EN ISO 13485:2016
- externer QMB
Do you need support with your quality management?
Contact us at any time for a free initial consulting
Quality management systems in medical technology
A customized quality management system is the best basis for constant safety and high quality of your products. It controls processes and workflows to meet customer requirements and at the same time maintain the safety and quality of your products.
Additional regulatory requirements now make a quality management system unavoidable in many cases. A quality management system does not have to generate additional work, but should support your company’s employees in their daily work.
The challenge lies in adapting a QM system to the company and not the other way around.
We do not sell QM systems, but advise you and work with you to develop an applicable and suitable QM system for your company. This means that you and your employees learn to work with it right from the start and feel familiar with it.
In addition, we can carry out internal audits (1st party audits) at your company and supplier audits (2nd party audits) at your partners in accordance with EN ISO 13485 on your behalf.
We can act as an external QMB for your company (in the short to medium term) to maintain and further develop your QM system.