Contact us: +49 (0)251 590 657 67
Do you need an updated Clinical Evaluation according to current regulations?
Are you planning to obtain a CE-mark for your medical device for the European market?
Do you need additional human resources?
Has the Notified Body revealed any deficiencies concerning your documentation?
Are you looking for regulatory and clinical affairs support?
Are you looking for external know-how and independent expertise?
We live quality and the requirements of ISO 13485, as well as the requirements of Regulation (EU) 2017/745. We are happy to work with your SOPs / templates on request.
Our team supports you in different areas of quality management: strategic planning of the QM system, creation of the manual, joint development of procedural instructions, independent implementation of internal audits, training, support in audits of your notified body.
We will show you how to coordinate your processes and SOPs so that they are ideally interlinked without inconsistencies.