Medical Devices
Medical devices are increasingly complex and your medical products need a competitive advantage: software.
Our medical software solutions and internal FDA-compliant processes encompass:
- Regulatory compliance (process compliance to ANSI/AAMI/IEC 62304) – we focus on what is required, and only what is required
- Staff augmentation – through our diverse expertise, we help free up your team.
- Tools and equipment – we utilize the most advanced, modern software development tools and electronic test equipment for medical device development
Our emphasis is on cost-effective technically superior solutions with first-time 510(k) approvals:
- Checklists – FDA Compliance Checklists are required for 510(k) / PMA. Atego HighRely has them
- Verification – develop in-house test platforms for SW unit level testing and automation scripts to expedite your schedule
- Program Management – verification of risk control measures. Risk management of software changes
- Training – reducing development and certification costs, schedule, and risk
- Reverse-engineering and GAP analysis: getting credit for pre-existing software without starting from scratch
- Utilizing FDA’s 510(k) and PMA development processes – comply with the FDA’s requirements:
- Architectural Mitigation
- System Safety Assessment Processes
- COTS Components Usage
- Product Service Experience
- 3rd party hardware design tools
- Information Flow (System Development Process – HW Design Life Cycle Process)
- Advanced Validation & Verification Methods
Related Links
The following associated products are available:
The following associated articles and white papers are available:
- Software tips for successful 510(k) submissions
- Medical Device Software Development for FDA 510(k) QSR/GMP Success
- Avoiding The Top 10 FDA 510(k) QSR Medical Device Software Development Mistakes
