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About ReguPartner

Expert consulting for Software as a Medical Device (SaMD) companies. At ReguPartner, we support medical device manufacturers—especially SaMD companies—through every stage of the regulatory and product development journey. Our team of experts helps you navigate complex MDR requirements, build strong Quality Management Systems (QMS), and bring safer products to market faster. 💡 Our Belief: A well-designed QMS should be a strategic asset—not a burden. We empower clients to maintain certification efficiently, so they can focus more on innovation and less on paperwork. 🔹 Executive Leadership Advisory CEO & CTO Advisory (Strategy, R&D, Organization) Financial Planning & MDR Project Budgeting Mergers & Acquisitions – Due Diligence Support Vendor & Partner Management (per MDR) 🔹 Regulatory Consulting Technical File & QMS Gap Analysis MDR Project Management QMS Development (ISO 13485) Risk Management (ISO 14971) PRRC Outsourcing (Person Responsible for Regulatory Compliance) Device Intended Use & Classification (per MDR) Internal Auditing & External Audit Readiness PMS & PMCF Planning (per MDR) CAPA Systems & Recall Strategy 🔹 Product Development Support SaMD Process Development (ISO/IEC 62304) Risk Assessment, FMEA & Change Management Significant/Substantial Change Assessments eIFU/IFU Development Quality Assurance, Verification & Validation 📍 Based in Sweden and serving clients across Europe and globally. 🔗 Visit regupartner.se or connect with us here to explore how we can support your regulatory and product goals.

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