One of the fastest-evolving fields in recent years, especially in connection with artificial intelligence, is telemedicine and medical software solutions. These technologies are increasingly used not only in hospitals and clinics but also directly in patients’ homes. With the enormous cost of healthcare, it’s no surprise that governments, insurance providers, and patients alike are eager to embrace innovations that can reduce expenses and save time, all while maintaining or even improving the quality of care.
The Medical Device Software (MDS) sector holds tremendous promise, but it’s not without significant challenges. Beyond the technical complexities of software development, companies must also navigate a complex web of regulatory requirements. It is in the public interest that only safe, high-quality medical products reach the market, products that prevent harm not only to patients but also to healthcare providers who interact with these systems.
To this end, medical device manufacturers must overcome both technical and regulatory hurdles. Every region imposes its own standards and legal frameworks. In the United States, the Food and Drug Administration (FDA) is the primary regulatory body. In Europe, manufacturers must comply with the EUMDR 2017/745 regulation, overseen by so-called Notified Bodies.
As a result, manufacturers are required to implement a wide range of procedures and documentation standards. These include:
- A Quality Management System compliant with ISO 13485
- The IEC 62304 standard governing the software development life cycle for medical devices
- A robust Risk Management process following ISO 14971
- Increasingly stringent Cybersecurity requirements, such as those outlined in IEC 81001-5-1
- And Information Security management systems aligned with ISO 27001
Despite this landscape of standards and regulations, no single guide or publication provides a definitive path through the process. Much of the expertise needed comes from experience, the number of audits a company has undergone, the CE certifications it has secured, and the challenges it has faced along the way.
This is precisely where medical device consulting companies can provide invaluable support. One such company is QMLogic, a consulting firm specialized in medical device software and regulatory compliance. QMLogic offers assistance with CE certifications in the EU under EU MDR, FDA submissions in the U.S., and a range of other regulatory challenges.
What sets QMLogic apart is its deep experience — its team has been through numerous CE certifications and audits, both internal and external. Their strong focus on software and software development ensures that their insights are not just theoretical, but grounded in hands-on, practical experience.
Whether you’re looking for an EU MDR consulting partner, guidance on implementing an ISO 13485-compliant Quality Management System, or support in developing software according to IEC 62304, QMLogic is the right place to start.
