Are you planning to develop a software as a medical device (SaMD)?
Then you have come to the right place. We implement your software medical device in accordance with the Medical Device Regulation (MDR) or FDA requirements and provide you with a customized project team of experienced software developers and regulatory experts. Depending on your needs, we will accompany you continuously or selectively and develop your medical device software according to your wishes in compliance with all legal requirements.
Arrange a non-binding consultation now to find out how we can best support you.
Development of software medical devices (SaMD)
We support you in all areas
Technical, as well as regulatory – our team has all the know-how necessary for the development of software medical products.
Software development
- Mobile apps
- Web applications
- Desktop applications
- Backend components
Information security
- Recognized security standards
- Penetration testing
- Information security management
- GDPR compliance
Technical documentation acc. to MDR/FDA
- Quality management (ISO 13485)
- Software lifecycle processes (IEC 62304)
- Risk management (ISO 14971)
- Usability engineering (IEC 62366)
Regulatory consulting
- Medical device approval
- Risk classification of medical devices
- Identification & implementation of MDR/FDA requirements
- Takeover of the manufacturer role
Process
From the idea to the implementation and operation of your medical device software – we support you throughout the entire product realization. In doing so, we flexibly adapt our services to your current project status. Depending on your needs, we develop your software and accompany you selectively, or over several phases and offer you those services that you just need.
1. Conception
- Requirements analysis
- Definition of the intended purpose
- Planning of the system architecture
- Selection of suitable technologies
- Definition of regulatory strategy
2. Planning
- Project planning
- Definition of the project team
- Clarification of responsibilities
- Identification of requirements (technical and regulatory)
- Prioritization of functions
- Risk analysis & planning of control measures (IT security and patient safety)
3. Software development and documentation
- Technical implementation of requirements
- Agile development of the software medical product
- Continuous Delivery
- Prototyping
- User tests
- Product labeling
4. Verification and validation
- Software testing
- Clinical evaluation & investigation
- Penetration Testing
- Security audits
5. Approval as medical device
- CE certification
- Generation of a UDI number
- Registration of the software medical device (e.g. EUDAMED)
- Accompaniment of audit by notified body (for risk class IIa or higher)
- Accompaniment of audits by regulatory authority
6. After approval
- Further technical development & change management
- User support
- Maintenance of the software medical device
- Post-market surveillance (PMS)
- Post-market clinical follow-up (PMCF)
- Incident reporting (vigilance)
QuickBird Medical as manufacturer
Through our internal quality management system (certified according to ISO 13485), we are also able to take over the manufacturer role for your product. In doing so, we take over communication with authorities and any regulatory responsibility for the product.
This allows you to fully focus on your core competencies – sales and conceptual development of the product.
This service is particularly interesting for companies that do not (yet) have a quality management system themselves.
Sounds interesting? Then contact us.
Are you planning to implement a software medical device (SaMD)?
Our team supports you in the planning and technical implementation of your app. You will benefit from our experience in the implementation of all regulatory requirements for medical devices. Contact us and arrange a no-obligation initial meeting. Let’s find out together how we can help you with your project.
QuickBird Medical
QuickBird GmbH
Nymphenburgerstr. 13-15
80335 Munich
