With this synergy, ECM positions itself as a reference partner for all Spanish and international startups revolving around the BHH. The goal is clear: to welcome and support young companies through the complex process of validation and market access, transforming the most revolutionary ideas into concrete solutions that comply with current regulations.
RESPONSIVENESS, FLEXIBILITY, AND TIME TO MARKET
In a sector where technological evolution moves fast, timeliness is everything. Aware of this challenge, ECM deploys three fundamental pillars:
- Immediate responsiveness: Quick replies and direct communication channels so as not to slow down the creative momentum of startups.
- Operational flexibility: Personalized and tailor-made approaches, capable of adapting to the specific and lean needs typical of new businesses.
- Focus on Time to Market: Optimization of testing and certification processes to minimize launch times, while ensuring maximum safety and quality.
We are ready to guide Spanish scientific innovation toward commercial success. The future of digital health starts here.
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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UPDATED THE LIST OF FAKE/FORGED DOCUMENTS
ECM – Ente Certificazione Macchine is informed of the existence of fakes/counterfeit certificates/laboratory test reports/other ECM documents relating to certain European Directives or International Standards. No one has permission to issue certificates or other documents in our name and on our behalf, so ECM will take action against any companies that issue certificates/documents without authorization.
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UPDATED LIST OF IMPROPER USES OF THE NAME ENTE CERTIFICAZIONE MACCHINE SRL AND/OR THE ECM NUMBER OF NOTIFIED BODY 1282
To consult the updated list of reports of misuse of the name Ente Certificazione Macchine srl and/or the notified body number 1282, click here.
22 Jun 2026
The voices of the Memorandum of Understanding (MoU) with the Korea Total Healthcare Ecosystem Association (KoTHEA): Gianluca Baldoni – Internationalization of the regional production system (Emilia-Romagna Region)
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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.
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IMPORTANT NOTICE: Immediate suspension of the use of the product “Hyperbaric chamber”
We would like to inform all our valued customers and business partners of an urgent measure that requires the utmost attention and timely cooperation from all users.