Full conformity-assessment journey under MDR and IVDR — classification, clinical evaluation, technical documentation and Notified Body coordination.
The EU MDR and IVDR have raised the bar significantly for medical-device manufacturers. Boem supports the full conformity-assessment journey — from initial classification through clinical evaluation, technical documentation review and (where required) Notified Body engagement.
We work with both established multinationals and emerging digital-health start-ups across class I, IIa, IIb and III devices, plus Software as a Medical Device (SaMD) under the new regulatory frameworks.
For market access beyond the EU, we coordinate FDA 510(k), Saudi SFDA registration, China NMPA filings and Eurasian RU MED through our partner network — keeping a single point of contact.
Tell us your target markets and we'll come back within one business day with a clear scope and timeline.
