Contact us: +49 (0)251 590 657 67
Do you need an updated Clinical Evaluation according to current regulations?
Has the Notified Body revealed any deficiencies concerning your documentation?
Are you planning to obtain a CE-mark for your medical device for the European market?
Are you looking for regulatory and clinical affairs support?
Do you need additional human resources?
Are you looking for external know-how and independent expertise?
Our templates were developed based on our experience with clinical evaluation according to MEDDEV 2.7/1 Revision 4 and adapted to the requirements of Regulation (EU) 2017/745 as well as MDCG 2020-1, MDCG 2020-5, MDCG 2020-6 and MDCG 2020-13. Upon request, we are also happy to work with your SOPs/templates.
Our team supports you in risk analysis in various areas: Facilitation of RM team meetings, preparation of risk management documentation with all required documents, including risk management plan, risk analysis, risk assessment, risk management report and FMEAs and if required, we help you with medical expertise.
We show you how to align your processes and SOPs to avoid redundancies and having to collect data and perform analyses multiple times.
We thoroughly review your Risk Management File. Depending on your individual needs, we either work with your templates or use our tried and trusted ones.