Safe and secure from draft to finished product
It takes more than just a good idea and motivation to develop from first draft to a product ready to go on the market. The time, effort and ressources needed to achieve marketability are factors which are hard to oversee when starting out. When the finished product is to be approved for clinical use (e.g. according to the European Medical Devices Act 42/93/EEC), said effort often sky-rockets.
In order to let you concentrate on your core business, AXIOS 3D Services developes your medical devices or your medical software as contract developments. We dip into our experience in optical 3D measurement developing tracking and positioning solutions, data processing applications and system integration for your projects.
Development according the Medical Devices Act
Within the field of optical measurement technology, we develop your medical devices according to all device-relevant guidelines and directives. This includes the documentation of the whole development process, ensuring traceability from start to finish. If desired, we also prepare your product and all documents for approval as medical device according to 42/93/EEC.
If you have any questions or would like to get more information, we are looking forward to hearing from you. Please get in touch!
Drafts and Planning
- Discussion of your ideas, drafts and concepts
- Evaluation of all requirements and costs
- Evaluation of risk class
- If needed: Support establishing a quality management system according to EN ISO 13485
Development
- Drafting a software development plan
- Risk analysis/ risk management according to ISO 14971
- Software specification and software architecture with focus on usability according to DIN EN 62366
- Development and implementation of algorithms
- Validation
- Technical documentation for medical software
Configuration management/ maintenance
- Source code management
- Software updates
Guidance through the certification process
- Support during the certification process
- Help with necessary documentation and papers
- Providing traceability of the whole software lifecycle
Why AXIOS 3D Services?
- Long experience with the development of software and software components in medical applications
- Certified according to DIN EN 13485 (since 2005)
- Developer and distributor of medical devices (Certificate of conformity 93/42/EWG, Appendix 2)
- Software developers and quality engineers with years of experience developing medical software
You decide, how much and which service you need:
- Support through all necessary steps for medical software according to Medical device guideline 93/42/EWG
- Development of algorithms, software libraries et cetera
- Complete development and documentation of the software project
- Guidance up to certification
Please contact us for more information and quotations.