CONTACT DETAILS
Take advantage of this extension of our Notification Scope and contact us to find out if your Medical Devices fall within our updated Notification Scope.
Contact our Sales Managers:
Diego Stevanella – diego.s@entecerma.it
Marzia Pellegrini – marzia.p@entecerma.it
Your Partner in Quality, Safety, and Compliance
The life sciences sector requires specialized knowledge and reliable support. With our broad expertise, we help organizations comply with laws and regulations, ensure quality, and continue to innovate with confidence.
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27 May 2026
The voices of the Memorandum of Understanding (MoU) with the Korea Total Healthcare Ecosystem Association (KoTHEA):Renato Biffi – Healthcare Italy Manager of Normec Group
The recent Memorandum of Understanding (MoU) signed with the Korea Total Healthcare Ecosystem Association (KOTHEA) marks a turning point for the biomedical sector, combining the technological excellence of the Republic of Korea with European industrial dynamism. The event, which featured a gathering of high-level international authorities and guests, highlighted the strategic relevance of an agreement that promises to redefine the dynamics of global cooperation in the healthcare and medical devices sector. To fully understand the scope of this agreement and its future prospects, we gathered the testimony of Renato Biffi, Healthcare Italy Manager of Normec Group.
18 May 2026
Strategic Partnership Between Italy and South Korea: Memorandum of Understanding (MoU) Signed for Innovation in Digital Healthcare
The official signing ceremony for the Memorandum of Understanding (MoU) with the Korea Total Healthcare Ecosystem Association (KOTHEA) was held on May 15, 2026, at the Ente Certificazione Macchine (ECM) headquarters in Valsamoggia (Bologna). The agreement marks the beginning of a collaboration aimed at facilitating access for Korean companies to the European medical device market.
13 May 2026
CASE HISTORY – MACHINERY SAFETY: COMPLIANCE OF CUBE ICE CREAM MACHINES
Through a rigorous process of technical evaluation and laboratory testing, the compliance of the CUBE gelato machine with the EMC Directive has been verified, validating the technological excellence and safety of a product that symbolises ‘Made in Italy’ worldwide. In the landscape of catering equipment and food craftsmanship, safety is not merely a regulatory obligation, but a cornerstone of manufacturing quality. Cube S.r.l., a company of excellence based in Montebello della Battaglia, has chosen to submit its professional gelato machines to a comprehensive certification process, ensuring maximum protection for operators combined with high-level performance.
12 May 2026
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The rise of e-bikes (or pedal-assist electric bicycles) is a rapidly growing phenomenon, fueled by ecological transition policies and the demand for more sustainable urban mobility. However, this increasing popularity imposes a fundamental responsibility: ensuring that these vehicles, which combine mechanics and electricity, are not only efficient but, above all, safe for the end user.
11 May 2026
Li-ion Batteries: Safety, Data and Global Certification
Lithium-ion (Li-ion) batteries represent the beating heart of the global energy revolution. They power electric mobility, portable devices, and storage systems, yet their widespread adoption raises urgent questions about safety. The risk of thermal runaway makes regulation and certification not only a legal obligation but a key competitive factor for the entire supply chain.
08 May 2026
Efficiency and Predictability: The Value of Express Service in Certifications
In the medical device and industrial quality sectors, time is not merely a variable but a critical success factor. The complexity of regulatory frameworks, such as the MDR and ISO standards, demands impeccable deadline management from manufacturers. In this context, ECM’s Express Service emerges as a strategic organizational solution for those requiring rigorous planning and the elimination of unforeseen delays.
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South Korea: The New High-Tech Frontier for Medical Devices
While the world looks East for digital innovation, a silent but powerful revolution is rewriting the rules of global healthcare. South Korea is no longer just the land of electronics giants and K-pop: it has officially transformed into one of the world’s most influential hubs for the medical device sector. But what makes this market so magnetic for international companies and investors? The answer lies in a “perfect mix” of structural and demographic factors.