SOFTWARE MEDICAL DEVICE
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Regulatory
Risk classification depends exclusively on its intended purpose, covering functions such as:
Under EU Regulation 2017/745, Medical Device Software (MDSW) is defined as any software intended by the manufacturer to be used on human beings for medical purposes.
- Diagnosis and prevention of diseases or pathological risks.
- Treatment, alleviation or mitigation of injuries or ailments.
- Monitoring, prediction, prognosis of health or control of conception.
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In the EU, software medical devices are governed by Regulation (EU) 2017/745 (MDR)
Software intended to generate a result that provides a clinical benefit (diagnosis, treatment, prevention, monitoring, etc.) is classified as follows.
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CLASS I:
All other software that does not fall into the higher risk categories.
CLASS IIa:
Solutions that provide information for standard diagnostic or therapeutic decisions, or intended for general monitoring of non-vital physiological processes.
CLASS IIb:
When an incorrect result could lead to decisions with a serious health deterioration impact or require surgical intervention. This also includes continuous monitoring of vital physiological parameters in situations of immediate danger.
CLASS III:
Reserved for software whose critical diagnostic or therapeutic decisions can directly determine the patient’s death or an irreversible deterioration of their health.
OUR CERTIFICATIONS
We manufacture under the industry’s most demanding standards
We manage the CE marking process and have proven experience accessing key international markets, including registration with ANVISA (Brazil) and FDA authorization (USA).
At Transmural Biotech, we place information security and patient privacy at the core of our strategy. In compliance with Royal Decree 311/2022, of 3 May, which regulates the National Security Framework (ENS) in Spain, our information systems have obtained Conformity Certification at the HIGH Category, the most demanding level under the Spanish regulatory framework.
CE Marking (MDR)
AEMPS License
Medical device certified in Europe
Authorized manufacturer of medical devices
ENS High Level + ISO 27001
ANVISA
Commitment to Security and Regulatory Compliance: ENS High Category Certification
Regulatory presence in the Americas and the U.S.
LICENSES
Manufacturer license
We hold a manufacturer license
In-house team
In-house team for preparing technical/regulatory documentation according to requirements.
Certifications
We are certified in ENS High Level, ISO 2700X, etc.
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Third-party CE marking service
We put our technical and regulatory expertise at your service to guide you through the entire international certification process. We streamline validation timelines and ensure your medical software complies with the strictest regulations, mitigating commercial risks and guaranteeing agile, secure access to the global market.
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