In addition to ISO 13485, we are also ISO 27001 certified because information security is important to us

In addition to ISO 13485, we are also ISO 27001 certified because information security is important to us

As an innovative company in medical technology, we have decided to become certified according to ISO 13485 and now, more recently, also ISO 27001 to ensure both the quality of our products and the security of sensitive data. This step strengthens the trust of our customers and allows us to meet the highest regulatory requirements.

ISO 13485: Quality and Safety
With ISO 13485:2016, we have optimized our processes for the development, manufacturing, and maintenance of medical devices. The focus is on:

• Risk Management: We identify and mitigate potential risks early to guarantee patient safety.
  • Documentation and Traceability: Our meticulous documentation ensures that all steps are traceable and the highest quality is maintained.

ISO 27001: Data Protection in the Digital Medical World
With advancements in medical technology, our products are increasingly connected to digital networks and systems. Particularly in the area of digital health applications (DiGA), protecting sensitive data is essential. That is why we have decided to additionally obtain the ISO 27001:2022 certification for information security management.

• Protection of Sensitive Data: Thanks to ISO 27001, we have implemented a system that ensures the confidentiality, integrity, and availability of data. This is crucial in an industry that increasingly relies on connected devices and cloud-based systems.
  • Risk-Based Approach: ISO 27001 has taught us to recognize and proactively manage security risks early on. This involves not only technical solutions but also organizational measures and employee training.
  • Building Trust: For us it is important that our customers trust that their sensitive data is in secure hands. The ISO 27001 certification further strengthens this trust.

The Synergies of Dual Certification
The combination of ISO 13485 and ISO 27001 has enabled us to develop a comprehensive management system that focuses on both product quality and data security. Both standards are based on similar principles, such as leadership responsibility, risk management, and continuous improvement. These synergies have made it easier for us to integrate both systems seamlessly into our existing processes.

What Does This Mean for Our Customers?
For our customers, our dual certification means they can rely on products that meet the highest quality standards while being secure in handling sensitive data. The regulatory requirements covered by both ISO 13485 and ISO 27001 ensure that we comply with strict legal and data protection regulations – both nationally and internationally.

Our Conclusion
Achieving certification for ISO 13485 and ISO 27001 was an intensive but rewarding process for us. We are proud to have reached this milestone and view it as an important step towards continuing to bring first-class, secure, and innovative medical products to the market. With these certifications, we reinforce our commitment to quality, safety, and data protection – to the benefit of our customers and the patients who rely on our products.

STAPPONE products support patients, orthopedic specialists, sports physicians, and physiotherapists in faster rehabilitation, objective diagnosis, and comprehensive treatment. Do you have any questions about the product? Contact us! We are always happy to assist you.