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Medical Device Software Regulatory Consulting
Because of our expertise, AIA has obtained and maintained regulatory approvals for complex software and AI/ML algorithms for several global companies. Whether you're developing medical device software or seeking quality and regulatory support for your existing product, contact us to learn how we can help bring your medical device software to market.
AIA has 10+ qualified technical experts specialised in not only Artificial Intelligence, Machine Learning, SaMD development but also the following medical device compliance knowledge:
1- EU/UK Medical Device Regulation (MDR)
2- U.S. Food and Drug Administration (FDA) Regulation
3- ISO/IEC Standard: IEC62304, IEC 8234, IEC 62366, ISO 13485, ISO 14971, etc.
Software Quality
Provide medical device software quality and regulatory advice
Quality Management
Help you implement ISO 13485 Quality Management System (QMS)
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Software Support
Support you to get regulatory approval for your SaMD
SaMD Development
AIA is an ISO 13485 certified software company and we deliver high-quality solutions adhering to medical industry standards.
We take care of software risks before your submission process. Our rich experience, attention to detail and follow-through ensure your SaMD project has all of the appropriate information, a correct process, and the necessary architecture to meet its compliancy requirements.
To help you build software intended for UK MHRA, EU MDR or FDA certification, AIA will
Gather documentation
We will gather software documentation and ensure the quantity and content of documentation meet the requirements for the regulatory certification
Develop software
We will conduct user surveys, design UX/UI, plan technology and architecture, and software test, creating SaMD of the highest quality.
Comply with regulations
We will develop your software to comply with MHRA, MDR, or FDA certification requirements so you can focus on innovations to meet patients' needs.