Why quality management in accordance with DIN EN ISO 13485 is also worthwhile if no medical device is being manufactured

Quality management – one term, many opinions. Quality management (QM) is often dismissed as unnecessary in software development or, at best, seen as a tedious chore. At first glance, introducing and maintaining a QM system ties up time, resources and costs without directly contributing to value creation. As a project manager and consultant, it is a constant challenge to convince decision-makers and customers of the importance and necessity of a structured QM system and to integrate it into project planning and budgeting. This is particularly difficult because the consequences of poor or inadequate quality management often only become apparent after the project has been completed – in the form of high maintenance costs, customer dissatisfaction or even product failure.

In the life sciences and healthcare sector, it is much easier to convince project managers of the necessity of quality management. After all, patient safety, data protection and integrity, and regulatory requirements are the main focus here. DIN EN ISO 13485 (ISO 13485) must be taken into account when developing medical devices. But what if, after testing, it is determined that the software product being developed is not a medical device? Is it still worth establishing an ISO 13485-compliant quality management system? I will explain the advantages of this additional effort below.

Why is quality management essential in digital health and life science projects?

As a general rule, structured and active quality management makes it easier to overcome a number of challenges:

• Regulatory requirements regarding compliance with data protection regulations (e.g. GDPR), information security standards (e.g. ISO 27001), risk management and industry-specific guidelines.
• Process reliability and scalability are ensured through clear processes and clean documentation. This sets the course for long-term success and compliance – even when scaling up.
• Market access and trust among users, customers and partners are strengthened through transparency and traceability in product development, and expectations in this regard are met.

Why implement the comprehensive and strict ISO 13485 when ISO 9001 also exists? Especially if you're not planning to develop medical devices? First of all, every product benefits from having a quality management system in place. ISO 9001 is no less beneficial in this regard. So let's take a look at the differences between the two QM standards as they relate to the healthcare industry:

ISO 9001 vs. ISO 13485 – what are the differences?

DIN EN ISO 9001 is a cross-industry standard that focuses on continuous improvement and customer satisfaction. The standard thus provides a solid foundation for a QM system, although it is general in nature and not specifically tailored to the requirements of the healthcare and medical technology sectors.

ISO 13485, on the other hand, was developed specifically for the development of medical devices and contains more extensive or stricter requirements in the following areas:

• Regulatory compliance: A stronger focus on regulatory requirements and documentation obligations.
• Risk management: A risk-based approach in all phases of product development to minimise or eliminate harm to humans.
• Traceability and documentation: Stricter requirements for change management and the traceability of processes and adjustments.
• Validation and verification: Clear guidelines for the validation of software and processes to ensure safety and effectiveness.

When is it worthwhile to introduce ISO 13845 for life science and healthcare software projects?

Many companies shy away from the higher requirements of ISO 13485, especially if the product to be developed has not been classified as a medical device.

This is because stricter rules usually mean more effort in introducing and enforcing the QM system. However, ISO 13485 is particularly worthwhile for health and life science products, for example when considering the following scenarios:

1. Long-term scalability

• If future versions of the software could contain functionalities for medical devices, it is easier if a compliant QM system including comprehensive product and project documentation is already in place.
• The same applies if the developed product is subsequently reclassified as a medical device following a reassessment of the medical device classes.

2. Trust and market access:

• Certification according to ISO 13485 can gain the trust of customers, users and partners and thus serve as a selling point. This is particularly advantageous when high safety standards are required, as is the case in the life sciences and healthcare sectors.

3. Optimised processes and risk minimisation

• The structured approach to risk management in ISO 13485 can also help to identify risks at an early stage and avoid errors in projects that are not related to medical devices.

4. Efficient cooperation with medical device manufacturers

• If the company works with certified partners or supplies components for medical devices, ISO 13485 certification and implementation for the relevant products is a competitive advantage or even a requirement of its own customer base. This is also one of the reasons why adesso Life Sciences is certified according to ISO 13485.

Conclusion

Even though software for the life sciences and healthcare market is not a dedicated medical device, a quality management system in accordance with ISO 13845 can still be worthwhile. It ensures clear processes and improved, structured documentation, thereby facilitating implementation and increasing the quality of the final product. It can also strengthen the trust of customers, users, partners and investors.

Companies or project teams that address the requirements at an early stage will benefit in the long term from better scalability, regulatory certainty and structured risk management. In the life science and healthcare environment in particular, it is worth going the extra mile between ISO 13485 and ISO 9001 in order to exploit business advantages and develop secure software. The decision for or against ISO 13485 is therefore not only a question of legal obligations, but can also be a strategic consideration. In any case, the software product to be developed will benefit from a well-implemented and lived QM system.