thinqbetter UG

thinqbetter stands for a future full of prospects: Because we show ways where others only see obstacles.

Together with us, you can turn regulatory requirements into a valuable advantage over those who do not know that direction. We work with core values for which we stand. Trust and reliability are our compass!

We provide global regulatory consulting services in the field of biomedical engineering. We are experts for medical devices and IVDs.

We support you especially in the following topics:

– Clinical Evaluation according to MEDDEV 2.7-1 rev. 4, MDD and MDR
– Quality Management according to ISO 9001, ISO 13485, MDSAP, 21 CFR 820
– Risk Management according to ISO 14971
– Post-market Surveillance
– Product Registrations in Europe and USA

Company’s Keywords:

digitaleversorgunggesetz, 21 cfr 820, clinical evaluation, klinische bewertung, iso 13485, qualitatsmanagement nach iso 9001, mdsap, postmarket surveillance, produktzulassungen usa und europa, risikomanagement nach iso 14971