August 04, 2025
Regulatory

A One-Stop-Shop for Medical Device Testing and Certification

Applus+, a global leader in testing, inspection and certification, is proud to announce the acquisition of Notice Belgelendirme Muayene ve Denetim Hizmetleri A.Ş. (“Notice”), a Notified Body for Medical Devices, headquartered in Kartal, Istanbul Province, Turkey, with additional operations in Slovenia. The new company will become part of Applus+ Laboratories. 

 

This acquisition marks a significant milestone in Applus+ Laboratories’ journey as a leader in the medical devices industry. By integrating Notice’s regulatory expertise with their global testing infrastructure, they can now offer their clients a one-stop-shop solution. This includes product testing, product certification in Europe, and system certification. Such an integrated service portfolio serves companies navigating the complex and evolving regulatory landscape of the medical device industry, including the MDR transition, enabling them to bring safer, more effective products to market. 

 

With laboratories across Europe, North America, and Asia, Applus+ Laboratories has built a strong foundation in medical device testing. Their capabilities span biomechanical testing, chemical testing including biocompatibility, packaging testing, EMC and electrical safety, cybersecurity, and specialized services for implants and dental devices. Their laboratory accreditations allow them to meet regulatory requirements in key global markets, including the FDA in the United States and the NMPA in China. With the addition of Notice as a Notified Body under MDR in Europe, they now offer a global compliance pathway — enabling their clients to demonstrate compliance across all major regulatory frameworks.  

 

Founded in 2016, Notice is designated as a Notified Body under MDR (NB 2764) and accredited by TÜRKAK under ISO/IEC 17021-1 to certify quality management systems in accordance with ISO 13485. The company exclusively serves the medical device sector, assessing manufacturers’ compliance with the rigorous regulatory requirements of the European market. 

 

“We are delighted to welcome Notice to Applus+ Laboratories. Their proven expertise in MDR certification significantly enhances our ability to serve as a comprehensive regulatory gateway for medical device manufacturers worldwide. Notice completes our business portfolio, enabling us to provide a fully integrated service that merges global testing capabilities with expert regulatory approval services for major international markets” said Mauricio Úbeda, EVP at Applus+ Laboratories. 

 

“Joining Applus+ Laboratories is a major opportunity for Notice. Being part of a group with such advanced testing infrastructure allows us to offer our clients a broader and more integrated service. Together, we are creating a stronger value proposition for medical device manufacturers, contributing to innovation and ensuring patient safety” said Ilker Eker, Co-Founder and CEO at Notice. 

 

As the medical device industry navigates the transition from Medical Device Directive (MDD) to the new Medical Device Regulation (MDR), Applus+ Laboratories is committed to being a trusted partner —providing conformity assessment services for medical devices manufacturers to demonstrate regulatory demands while accelerating innovation that improves lives. 

 

Source: Applus+