Software as medical device

Software is playing an increasingly vital role in medical devices, in vitro diagnostics (IVD) devices, and their accessories. For regulatory, ethical, and financial reasons, businesses need to ensure that the software is developed, validated, and maintained properly. 

In response to this need, many markets are creating medical software regulations. Regions with these regulations include the USA, EU, China, Australia, and the UK. Medical device software compliance with these regulations is essential for entering these markets.

Regulations such as the European Medical Device Regulation (MDR) and In Vitro Diagnostics Medical Device Regulation (IVDR) define specific software requirements under the “general safety and performance requirements” in Annex I. Similarly, the FDA provides guidance, such as the “Software as a Medical Device (SaMD): Clinical Evaluation”, which outlines the software-related criteria that must be met.

In the competitive field of medical software, companies face significant business challenges when developing and bringing a regulated product to market. Creating software that not only meets the needs of users but also complies with regulatory standards is a complex task. 

Companies must navigate quality management requirements, software lifecycle standards, risk management processes, and cybersecurity concerns — all while maintaining an innovative edge in a rapidly evolving market. The challenge is to balance product development speed and quality assurance with the need to meet regulatory demands to ensure patient safety and product reliability. 

Failure to ensure proper software design, validation, and management in a medical device could lead to severe consequences. Software defects or malfunctions in medical devices can compromise patient safety, potentially resulting in injury or even death. If software risks are not effectively minimised or managed, they could lead to unintended device behaviour, malfunctions, or operational failures. These complications could disrupt treatment, delay care, or cause harm.

Furthermore, medical devices handle sensitive patient data, so companies must have strong data protection measures in place. Non-compliance with privacy regulations can lead to hefty fines, legal liabilities, and damage to trust. 

As a result, global regulatory bodies show an increasing awareness of cybersecurity for medical devices. For example, the FDA, the European Commission, and Health Canada have published guidelines on how to meet cybersecurity regulations. 

These guidelines raise awareness of the necessity to carry out vulnerability scans, penetration tests or other security tests throughout the whole lifecycle of a medical device. This is essential for continued safety, quality, and compliance with medical software regulations. 

To comply with the applicable regulations, medical software companies must establish quality management systems, integrate comprehensive risk assessments, and demonstrate their software's safety and effectiveness throughout its lifecycle. Evolving regulations and the intricacies of software classification make continuous training on changing regulatory and technology standards necessary.

As TÜV SÜD, we provide services to you with our holistic experience in the field of Software as Medical Device. Our industry and software development professionals ensure that your association with TÜV SÜD certification and testing services are a valuable step in bringing your product to the market.

TÜV SÜD is fully equipped to certify your software products in line with ISO 13485, ISO 62304, and EU Medical Device Regulation (MDR) requirements.

Our services go beyond mere certification. They provide a streamlined process that respects your development cycles and aligns with your product's specific requirements.

By working with TÜV SÜD, you gain a trusted partner who understands the nuances of software as medical device, so you can build your credibility in a regulated market. 

Our industry experts understand from their experience that software products are developed differently from hardware-based medical devices, requiring a more agile approach to meet both technical and regulatory requirements.

Our experience with software products means we know the specific needs and pressures you face, from managing rapid updates to ensuring compliance with changing regulations.

TÜV SÜD's certification and testing services are independent of each other and do not impact one another. Our certification services are delivered by TÜV SÜD's recognized Certification Bodies, while our testing services are conducted through TÜV SÜD Testing Labs

Securing a medical device starts in the design stages and includes a secure development lifecycle process, security risk management process, tests to verify and validate the “security implantations” and “security risk mitigation measures”, and a security post market process. 

The primary means for the verification and validation tasks are penetration testing, vulnerability scanning and fuzz testing, security feature testing and source code review. 

We perform additional tests to identify components with known issues. In the rapidly evolving field of medical technology, certification for software-based medical devices is essential. 

We offer ISO 13485, ISO 62304, and EU Medical Device Regulation (MDR) related certification services, ensuring that your products meet the highest standards in quality management, software development, and regulatory compliance.

ISO 13485 and ISO 62304 certification

ISO 13485 certification demonstrates a commitment to consistent quality and patient safety. It shows stakeholders that your products adhere to the stringent requirements of the medical device industry.

ISO 62304 certification ensures that your software is developed and maintained using state-of-the-art practices. This enhances both safety and reliability.

MDR certification

Our MDR certification services verify compliance with complex EU regulations, focusing on software qualification, classification, and cybersecurity. By achieving these certifications through TÜV SÜD, your company meets regulatory demands, builds trust, strengthens its reputation, and gains a competitive advantage in the medical technology sector.

Cybersecurity testing for medical software

Cybersecurity is a critical aspect of software as medical device, especially given the increasing digital threats in healthcare. Understanding this, we offer comprehensive cybersecurity testing for medical software. We test your software robustly against unauthorised access and data breaches. We address both compliance and security, helping you bring a safe, reliable, and secure product to market.