Whether embedded or standalone software: the purpose determines whether software is to be classified as an (independent) medical device.
We support you from there onwards and accompany you through all the steps of development. You will be involved in our development process, which is preferably agile. For us, agil means first of all: requirements are always welcome, at any time. And secondly, we deliver results that you can check at any time — even during development.
In addition, we develop test driven. Writing many automated tests serves the stability and good architectural design that are essential for a medical device.
The standards relevant for software development, such as IEC 62304, must be observed in every development process. For this reason, software development ends with documentation that is compliant to standards, which we produce during development.
Development of electronics
Your company wants to develop, approve or produce a medical product? Thanks to our many years of experience, we can support you in ever phase of the development process. We find the right step in the process to accompany you from the idea to approval, if desired. Our compact multidiciplinary team supports you finding a fast, cost-efficiant and high quality solution.
Our large-volume generative manufacturing system from German Reprap and our 3‑axis CNC milling machine from Isel with modern high-frequency spindle ensure the fast production of high-quality functional samples. Our network of partners in the region includes computer-aided metal part machining (CNC), printed circuit board manufacturers and generative manufacturing technologies companies to produce first-class prototypes for your product. The assembly of mechanical assemblies and electronic circuits can be carried out on site. We are looking forward to turning your concept into reality.
Project coordination and management
In addition to the development of mechanical and electrical components, software technology in particular has become increasingly important in recent years. Due to the digitization and networking of the different systems, a large number of other disciplines have been brought on the agenda, each of which can only be fulfilled by highly specialized IT providers.
Due to the high degree of specialization of the development service providers in their individual core competences, however, it is increasingly necessary that the development of complex medical technology systems can only be carried out in cooperation.
In addition to traditional engineering offices, this includes specialized software providers supported by university institutes and clinical partners. Experienced project coordination is crucial for these heterogeneous consortia to work together effectively. SurgiTAIX has 15 years of experience in coordinating research projects as well as industrial projects and speaks the “languages” of the various cooperation partners.
Consulting: Quality and risk management service providers
Quality and risk management are two concepts that are inherently linked to medical devices. In accordance with the Medical Devices Act, every manufacturer of medical devices is obliged to provide technical documentation for each of its products. This documentation must be prepared in accordance with a quality management system and maintained throughout the entire lifecycle of the product.
In particular, the following laws, standards, and directives must be complied with:
- Medical Devices Act (“Medizinproduktegesetz”)
- Directive 93/42/EEC and MDR (Medical Device Regulation)
- Quality management according to DIN EN ISO 13485
- Risk management according to DIN EN ISO 14971
- Electrical safety DIN EN 60601–1
- Usability test according to DIN EN 60601–1‑6
- Software development according to DIN EN 60601–1‑4 and DIN EN 62304
SurgiTAIX AG offers an adapted consulting package especially for new companies and spin-offs. We offer all consulting services from a single source, starting with the development of a QM system, support in the creation of technical documentation and support during the approval process.
In addition to pure consulting services, we offer training courses and lectures on the following topics:
- Quality management for medical devices
- Risk management for medical devices
- Technical documentation
- Directive conformant development of electronics, software, and hardware
- Electrical safety
The highest quality and safety are at the forefront of our services. Benefit from our many years of experience in quality and risk management for your products!