OPERATE WITH CONFIDENCE: THE POWER OF A LOCAL PRESENCE
Foreign market dynamics can often appear complex. Our international outposts were established to address this very challenge: enabling our clients to operate globally with total peace of mind. Having a local presence means managing every stage of the process directly, ensuring constant control over quality and flow compliance. We are not merely observers; we are an integral part of the region, with a team that possesses deep knowledge of local dynamics and regulations.
A SPACE BUILT FOR THE FUTURE
The locations featured in the video reflect our core philosophy. We have created environments that foster well-being and collaboration, rooted in the belief that a stimulating atmosphere is the fertile ground where innovation thrives. Design excellence and technological functionality merge to welcome partners and collaborators within an international framework, where every detail communicates solidity and transparency.
MEETING CHALLANGES, REACHING GOALS
By combining global experience with the responsiveness of our local teams, we transform logistical and bureaucratic complexities into growth opportunities. We are on the ground to ensure your business has no borders, providing the peace of mind that comes from having a strong, reliable partner always by your side.
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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19 Jun 2026
The voices of the Memorandum of Understanding (MoU) with the Korea Total Healthcare Ecosystem Association (KoTHEA): Choi Taeho – Consul General of the Republic of Korea
International ties and strategic development prospects are strengthening around the crucial Memorandum of Understanding (MoU) signed at the Valsamoggia headquarters between the Korea Total Healthcare Ecosystem Association (KoTHEA) and the European notified body Ente Certificazione Macchine (ECM). The official ceremony was graced by the prestigious participation and institutional support of Choi Taeho, Consul General of the Republic of Korea, who emphasized the high political and economic value of this agreement. The agreement represents not only a technical milestone but also a genuine turning point in industrial and regulatory relations along the Seoul-Rome axis, fitting into a rapidly evolving global macroeconomic framework.
18 Jun 2026
New Machinery Regulation, the entry into force approaches: what’s new for Manufacturers
The European regulatory landscape is undergoing a crucial transformation with the introduction of Regulation (EU) 2023/1230, which will permanently phase out the historic Machinery Directive 2006/42/EC. One of the most impactful changes concerns the obligation to integrate cybersecurity as an essential element of product safety.
18 Jun 2026
A Turning Point for Cybersecurity in Europe: What’s New in the Cyber Resilience Act
The global market for connected devices is facing an unprecedented regulatory revolution. With the introduction of the Cyber Resilience Act (CRA), cybersecurity is no longer a strategic choice or an optional competitive advantage, but has become a strict legal requirement essential for bringing products to market in Europe. The CRA imposes strict new obligations on all products containing digital components. The European Union’s fundamental objective is clear: to strengthen the security of hardware and software by ensuring robust and continuous protection throughout the product lifecycle, from design to vulnerability management after the product is placed on the market.
18 Jun 2026
Occupational health and safety: the tragedy in Trentola Ducenta reignites the urgency of forklift safety
The toll of workplace fatalities in Italy shows no signs of abating, bringing the issue of safety and technological prevention back to the fore with dramatic regularity. The latest tragic incident recorded in Trentola Ducenta (Caserta), where 23-year-old worker Francesco Dergano lost his life, underscores once again that the risks associated with the maintenance, handling, and operation of industrial machinery are an absolute priority that must be addressed.
12 Jun 2026
The voices of the Memorandum of Understanding (MoU) with the Korea Total Healthcare Ecosystem Association (KoTHEA): Heekyung Jung – Secretary General of KoTHEA
A new era of international cooperation in the digital health sector begins. During the official ceremony held at our headquarters in Valsamoggia, the Korea Interministerial Healthcare Association (KOTHEA) and the European notified body ECM signed a crucial Memorandum of Understanding (MoU). The agreement aims to facilitate the access of Korean medical technologies into the European market. The next steps will involve close collaboration on the ground, led by KoTHEA’s Secretary General, Heekyung Jung, who attended the event in Italy to seal the launch of this practical cooperation.
11 Jun 2026
ECM in Palermo for the 61st CNB-MA Meeting: towards an increasingly harmonized European regulatory framework
ECM confirms its institutional commitment within the European technical committees of Notified Bodies, contributing to the evolution of the regulatory framework for machinery. An important European institutional appointment has concluded, which ECM took part in, confirming its commitment to active participation in the coordination committees among Notified Bodies. Our Press Office & Social Media Manager Luca Serra represented ECM in Palermo on the occasion of the 61st CNB-MA HC Meeting (June 9-10, 2026) dedicated to the Machinery Regulation 2023/1230.
05 Jun 2026
ECM joins the Barcelona Health Hub: a new era for digital health startups
ECM takes a decisive step toward the future of digital medicine by announcing its official entry into the prestigious Barcelona Health Hub (BHH) network. This strategic partnership combines ECM’s consolidated experience in medical device certification, testing, and compliance with one of the most dynamic global ecosystems dedicated to health innovation.