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SDLC Compliance is a specialized consultancy serving AI companies, digital health and MedTech companies in the US and EU since 2019. Founded by Ranj Zuhdi, we provide expert training, strategic advice, and consulting services tailored to the unique needs of Medical Device and health AI companies.
Our Core Expertise:
Implementing software and AI safety and assurance frameworks.
Creating and implementing quality management system (QMS) procedures compliant with medical device standards (e.g., ISO 13485, ISO 14971, IEC 62304).
Providing hands-on support and guidance on safety and security risk assessment, design assurance, verification and validation, and traceability.
We specialize in:
AI safety frameworks and standards.
Helping Healthcare Innovators Navigate Software Development for Regulatory Approval (CE Marking & FDA 510k).
Implementing risk management, design control and QMS for FDA and ISO/IEC standards compliance.
Conducting audits for: software life cycle documentation and quality procedures.
At SDLC Compliance, we take a pragmatic and lean approach to QMS and design assurance processes. Our niche focus on software quality, AI and software risk assessment, and design assurance services for Software as a Medical Device (SaMD) and regulated AI in healthcare sets us apart.
Our mission is to provide a modern approach to regulated software ensuring our clients meet the highest standards of safety and compliance while navigating the complex regulatory landscape.
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