Development of Software as a Medical Device (SaMD) – FDA & 21 CFR compliant
We develop your medical software or medical app in accordance with FDA requirements. We take care of design, software development, and 21 CFR compliance, and assist you with 510(k), De Novo, or PMA submissions.
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Development of Software as a Medical Device (SaMD)
We support you in all areas
Our team combines technical and regulatory expertise for the development of software medical devices in accordance with FDA regulations, including 21 CFR Part 820, 21 CFR Part 11, and relevant guidance documents.
Competencies
Quality Management System Regulation (QMSR)
- Quality Management (ISO 13485)
- Software Lifecycle Processes (IEC 62304)
- Risk Management (ISO 14971)
- Human Factors Engineering (IEC 62366)
Regulatory Consulting & Preparation of
DHF, DMR, DHR
- Medical Device Approval
- Risk Classification of Medical Devices
- Identification/Implementation of FDA Requirements
- Takeover of the Manufacturer Role
Our Process
From the initial product idea to the final implementation and operation of your medical software, we accompany you through the entire development process. Our support covers all phases, from concept, design, and software development to FDA-compliant documentation and submission.
1. Conception
- Requirements analysis
- Definition of the intended purpose
- Architectural concept according to FDA Design Controls
- Definition of regulatory strategy
- Definition of responsibilities
2. Planning
- Kickoff for agile design sprints
- Technical specification
- Prioritization of functions
- Risk analysis and planning of control measures according to 21 CFR 820.30
- Regulatory planning
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
- FDA-Submission – 510(k), De Novo, PMA
- Generation of a UDI number
- Supporting the FDA review process
- Q-submission (pre-sub) for early FDA feedback, if applicable
- Submission via the FDA CDRH portal (eSTAR)
6. After Approval
- Further development and change management
- User support
- Maintenance of the software medical device
- Post-market surveillance (PMS) according to FDA requirements
- Incident reporting (vigilance)
What makes us special
ISO 13485 certified
Our quality management system is certified according to ISO 13485. This enables us to ensure the compliant development of software as a medical device and to meet the requirements of the FDA & Quality Management Systems Regulation (QMSR) for quality management systems.
External placing on the market
If required, we can take over the role of the legal manufacturer for your medical device software. We therefore bear legal responsibility for compliance with all FDA regulatory requirements. This allows you to focus on your core competencies such as sales & marketing.
ISO 27001 certified
QuickBird Medical is certified according to ISO 27001 for information security management. Our team has extensive expertise in cybersecurity and in handling sensitive health data in compliance with data protection regulations.
About QuickBird Medical
QuickBird Medical is a Munich-based company specializing in the development of medical software. Our 30-strong team of developers, regulatory experts and UX designers work closely together on digital solutions that make medicine more effective, safer and more efficient.
We support our customers in implementing certified medical software: from certified digital therapeutics to complex web platforms for clinics. Always with a focus on quality, regulatory compliance, and genuine added value for patients and healthcare professionals.
Our Medical Software and DiGA customers
Are you planning to implement a software medical device (SaMD)?
Our team supports you in the planning and technical implementation of your software. You benefit from our experience in implementing all FDA 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.