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Medical Device Software Regulatory Consulting
Because of our expertise, AIA have obtained and maintained regulatory approvals for complex software and AI/ML algorithms for several global companies. Whether you're developing a 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 have qualified technical experts specialised in not only medical device software, Artificial Intelligence/ Machine Learning 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 medical device software
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
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Gather software documentation
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Design UX/UI, plan technology & architecture
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develop your software compliant with MHRA, MDR or FDA certification requirements.