MDR Consultancy
For those seeking clarity on clinical data required by MDR.
MDR is no longer a novelty: it has become part of day-to-day practice. However, the correct interpretation of requirements and the quality of supporting evidence remain critical—especially when it comes to audits and the assessment of technical documentation. Guidelines (MDCG) and standards (ISO 14155, ISO/TR 20416) provide clear reference points, but experience is needed to translate them into practical, sustainable decisions.
With a quick conversation, we can immediately understand where you are today and how to leverage what your company already has in place to achieve compliance effectively, without unnecessary complexity.
