Applus+ Laboratories Ensures Cybersecurity for INDIBA Medical Devices According to FDA Requirements

Headquartered in Barcelona and Treviso (Italy), INDIBA is a global leader in various sectors, such as aesthetics, rehabilitation, and animal health. With over 40 years of scientific research, INDIBA is renowned for its 448 kHz frequency technology, which is fundamental in its globally recognized therapies. The company is dedicated to improving people's quality of life and accelerating injury recovery through its innovative treatments.

Evaluating Cybersecurity for the US Market 

In this project, Applus+ Laboratories evaluated different INDIBA medical device products intended for the US market. These medical devices are designed for musculoskeletal rehabilitation and pain relief, and were assessed following the stringent requirements of the FDA. 

Addressing Cybersecurity Challenges 

The main challenge was to assess cybersecurity risks related to the presence of an attacker with physical access to the products, but without access to the internal hardware components. The tests focused on compromising the underlying operating system where the product is running, attempting to bypass kiosk mode, interact with the file system, or execute arbitrary commands. 

Meeting FDA Cybersecurity Requirements 

For the approval of medical devices, the FDA emphasizes comprehensive cybersecurity testing. Key areas include vulnerability testing, such as abuse cases, fuzz testing, attack surface analysis, and software composition analysis. Penetration testing is also conducted, simulating attacks to identify security weaknesses. Reports must cover the independence of the evaluators, the scope, methods, and results to ensure thorough evaluation. 

Achieving Results with Efficiency 

Thanks to the excellent support from INDIBA, Applus+ Laboratories successfully evaluated the three products simultaneously, completing the evaluation in record time. The seriousness and efficiency with which the team worked were highly valued by INDIBA. 

Applus+ Laboratories: Experts in Cybersecurity 

Applus+ Laboratories has over 20 years of experience as a cybersecurity laboratory, offering services for various types of products and fields such as hardware, software, communications, and cryptography. The company has worked in diverse markets, including payment systems, automotive, Internet of Things, industrial cybersecurity, and defense. This extensive experience positions Applus+ Laboratories as experts in cybersecurity for medical devices, a sector in which they are committed to becoming leaders in testing, certification, and market access services. 

Client Satisfaction 

INDIBA expressed their satisfaction with the cybersecurity evaluation. "The collaboration with the team has been excellent," commented Joan Brossa [INDIBA R&D Engineer].

Commitment to Cybersecurity 

"We are delighted to collaborate with INDIBA and to ensure that the medical devices reaching the market are cybersecure," stated Jose Francisco Ruiz, Director of the Cybersecurity BU at Applus+ Laboratories.