Newsletter & Events - June 2025 - Happy Whitsun Holidays 😎
Change Management in Quality Management - The five phases of successful change
Changes in the medical technology sector are inevitable—whether due to new regulatory requirements, digital transformation, or strategic realignments. Whether you are implementing a RIM system (Regulatory Information Management System) or an electronic quality management system (eQMS), successful change management involves more than just adjusting processes and structures. What truly matters is how well people within the organization are integrated into the transformation process.
In-house IVDs under the IVDR: Why medical laboratories need to act now
With the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR), which came into force on May 26, 2022, in-house in vitro diagnostic medical devices - known as in-house IVDs or laboratory developed tests (LDTs) - have also come under stricter regulatory control. Many medical laboratories in Europe now face the challenge of continuing to operate these products in compliance with standards. What previously went largely unnoticed is now subject to extensive requirements: from risk management and performance evaluation to market availability testing from 2030 onwards. What requirements must medical laboratories already meet today for their in-house products? Which tests can still be manufactured and used as in-house IVDs? In this article, we provide a practical overview of the applicable obligations - and show what laboratories should now pay attention to in order to keep their in-house IVDs compliant and usable in the long term.
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Change Management in Quality Management: Successfully managing change in medical technology
Change is often necessary in the medical technology sector - whether due to new regulatory requirements, strategic realignments, or digital transformation. However, successful transformation requires more than just technical adjustments; it impacts processes, structures, and, above all, the people within the organization. A well-thought-out change management strategy can make all the difference - not only in ensuring a successful quality management audit but also in securing long-term success and sustainable competitiveness.
SWISS MEDTECH DAY - 25 June, 2025 in Bern
Please visit our Metecon Schweiz GmbH booth R10 and meet my collegues Marco Scicolone and Kerris Klug in person. Whether it's digitalization, IVDR implementation for Swiss manufacturers entering the EU market, or questions about CH-REP or EC-REP – we’ll show you how to navigate complexity with a strategic approach: Through expert consulting, practical solutions, and a forward-looking perspective on the future of medical technology.
Wishing you all wonderful Whitsun Holidays – enjoy the break and take some time to recharge 🌞
"It is not the strongest species that survive, nor the most intelligent, but the ones most responsive to change."~ Leon C. Megginson ~