As technology continues to advance, so do the medical devices that are used to sustain life. While in South Korea, various types of medical devices capable of communication have been developed, the development is accompanied by the risk of cybersecurity threats such as hacking of medical devices and information leaks. These threats are not only applicable to property loss, but also to patients’ lives, and that is why safeguarding medical device cybersecurity is a core concern.

The advancement of medical devices has revolutionized patient care and treatment outcomes.

Brazil, the largest economy in Latin America (LATAM), is also the most promising medical device market in the region. The medical device market in Brazil is governed by the Agência Nacional de Vigilância Sanitária (ANVISA), or the Brazilian Health Regulatory Agency, which came up with a new resolution titled RDC 751, effective from March 01, 2023.

Validation protocol is defined as a documented plan for testing a medical device to confirm that the production process used to manufacture the product meets the specific user, technical, and Regulatory requirements. This includes a review of process variables and operational limitations and the analysis of test results under actual use conditions.

The validation process involves several tangible actions. The steps are elucidated as follows:

In effect from March 1, 2023, the technical dossier must be planned as described in the Brazilian Health Regulatory Agency, or the Agência Nacional de Vigilância Sanitária (ANVISA)’s   new medical device regulation, RDC 751/2022. This blog provides you with an insight on technical dossier Regulatory compliance in accordance with the new resolution.

Innovations in medical devices have increased manifold in recent years. This acceleration can be especially attributed to the vast development in cloud computing and the Internet of Things (IoT). Similarly, Software as a Medical Device (SaMD) has seen an increase in demand and remains a major contributor to the overall growth of the device industry.

Although digitization and Internet of Things (IoT) have together enhanced the performance of medical devices, they have also made devices prone to cyber vulnerabilities. The malware and spyware invading the devices are growing. The hackers are mining for loopholes in devices and related software that allow them to corrupt the devices to compromise user data by malfunctioning the devices. All these adversities are hindering organizations’ efforts towards securing user data and preventing the damage.