Mastering Quality in Healthcare

Transform how your healthcare organization manages quality, risk, and compliance — from the inside out.
In today’s fast-evolving medical landscape, hospitals are under pressure to meet rigorous quality and safety standards. Enter the Medical Device Regulation (MDR) — Europe’s new gold standard for medical technology compliance. But what does this mean for your healthcare facility, and how do you implement it without chaos?

This master’s level research thesis, developed in collaboration with PwC and top Swedish healthcare institutions, delivers the most detailed, real-world roadmap for implementing MDR-aligned Quality Management Systems (QMS) in hospitals.

With a sharp focus on real challenges, regulatory alignment, and value-driven execution, this study walks you through how to build, adapt, and lead a QMS that complies with ISO 13485 and MDR, while truly improving patient care. It includes:

• Case-based insights from leading Swedish hospitals

• A proprietary gap analysis tool to streamline your QMS development

• Interviews with regulatory experts, risk managers, and healthcare leaders

• A practical framework for moving from compliance to excellence

Whether you’re a hospital leader, compliance officer, medical device manufacturer, or healthcare quality professional — this is your go-to blueprint for mastering MDR and transforming quality culture in your organization.

✅ What You’ll Get:

• A detailed guide to building MDR-compliant QMS tailored for hospital settings

• A breakdown of ISO 13485:2016 and how it harmonizes with EU MDR

• Insights into Swedish national regulations (SOSFS 2011:9 & HSLF-FS 2021:52)

• Real-world implementation challenges and how to overcome them

• A full, ready-to-use Gap Analysis Tool to assess and improve QMS readiness

• Key success factors: Culture, leadership, simplicity, and value creation

• Interviews with quality managers and hospital staff across multiple regions

• Extended theoretical frameworks and models for QMS excellence

• A complete academic and practical reference to support training and decision-making