Work. Commitment. Passion.
The medical device regulation is without question a big challenge for every manufacturer. At the same time, there is a shortage of professionals. I would like to show you how digitalization can help your company reduce costs, increase compliance and master MDR.
EU-MDR Implementation
EU Medical Device Regulation Implementation Roadmap and a smart approach.
Technical Documentation
Lean documentation according MDR and MDD.
Digitalization
Lower costs and gain compliance. Digitalizing RA, QA and R&D.
Skillset
Dedicated to medical devices.
EU - Medical Device Regulation 2017/745keyboard_arrow_up
Divisional MDR Implementation, compliant SOPs and a lean approach for a swift transition.
RA, QA, R&D Digitalizationkeyboard_arrow_up
Digital disruption in RA, QM and R&D will not destroy jobs. It will help today's professionals. Requirements such as the EU MDR will become affordable, while increasing compliance.
Technical Documentation according MDRkeyboard_arrow_up
Lean technical documentation in compliance with all regulatory requirements.
invert_colorsBiological Evaluation - ISO 10993-1keyboard_arrow_up
Biological evaluation of your products and monitoring of all necessary laboratory tests.
Clinical Evaluation according MDR / MEDDEV Rev.4keyboard_arrow_up
Support in the preparation of your clinical evaluation according to the latest guidelines and requirements.
UDI Implementation EU-MDR / US - GUDIDkeyboard_arrow_up
UDI on the production line, from data preparation to database transmission. GUDID and EUDAMED.
QM for Medical Devices - ISO 13485 (2016)keyboard_arrow_up
I support you in the creation of your QM system.
Risk Management - ISO 14971keyboard_arrow_up
Lively risk management has many advantages for the manufacturer. Together with the EU-MDR there are a number of exciting links.
International Labeling Conceptskeyboard_arrow_up
Requirements of many countries on a regional label can save costs. Market access is nevertheless secured.