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 while maintaining the safety and quality of your products.
Additional regulatory requirements now make a quality management system indispensable in many cases. A quality management system does not have to generate additional costs, but should support the employees of your company in their daily work.
The challenge is to adapt a QM system to the company and not vice versa.
MEDTECH360 supports and advises you in the implementation of a suitable quality management system for your company.
Furthermore, we can perform internal audits (1st party audits) in your company,
as well as on your behalf supplier audits (2nd party audits) according to EN ISO 13485 at your partners.
Our competences are therefore among others
- As-is analysis
- Introduction and implementation of a quality management system according to EN ISO 13485
- Quality management documentation
- Quality management briefings and training
- Internal audits according to EN ISO 13485
- Supplier selection and auditing according to EN ISO 13485