Oudegracht Conformity

Oudegracht Conformity is a small Utrecht consultancy that works with medical device makers, digital health companies and hospital IT departments on the intersection of the EU AI Act and ISO/IEC 42001. Most of its clients already deal with MDR or IVDR and want to know how the Act's high-risk requirements layer onto the technical file, quality management system and post-market surveillance they maintain today. The firm's answer is usually a joint programme: a gap analysis that reads the existing QMS against Annex III obligations and the 42001 clauses, then an implementation phase that extends rather than duplicates the documentation. Engagements are fixed-scope projects, typically fourteen to twenty-six weeks, with gap analyses for a single product family generally landing between fifteen and fifty thousand dollars. Shorter advisory calls are not sold separately. The eight-person team is based near the Oudegracht canal in central Utrecht and spends part of most weeks at client sites in the Netherlands, Belgium and Germany. Oudegracht helps clients prepare for and manage a third-party conformity assessment but is not itself a notified body, does not perform clinical evaluation, and does not write software.