Expertise that simplifies complexity.
At MED Compl.ai Solutions, we believe compliance should enable innovation, not slow it down. We guide medical device manufacturers, simplify compliance and strengthen their Quality and AI Management Systems.
With deep experience in Quality Management Systems, AI governance, and EU MDR compliance, we make complex regulations clear, practical, and scalable. We help turn regulatory requirements into efficient systems so you can focus on innovation and bring safe, compliant products to market with confidence.
Our approach combines hands-on expertise with clear communication, ensuring every client feels informed, prepared and confident at every stage of the compliance journey.
Our Services
Comprehensive expertise. Practical solutions.
From audit readiness to continuous improvement, we support every stage of your compliance journey.
QMS Readiness & Implementation
Our regulatory compliance services focus on interpreting complex regulations and supporting the development of tailored management systems to ensure adherence to quality and safety standards.
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ISO 13485 implementation guidance and support
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Applicable standards GAP analysis
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CAPA, Complaint Management, Supplier Management & Training strategies
Internal and Supplier Audits
Comprehensive ISO 13485, EU MDR and FDA 21 CFR 820 audits that deliver clear, actionable reports outlining findings, risks, and required actions. Prioritized CAPA and remediation guidance to close gaps efficiently, along with independent compliance verification that strengthens your QMS and enhances supplier performance.
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Internal Audits in accordance with applicable standards
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Clear guidance on non-conformities resolution
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Supplier Management Strategy and Audits
AI Management System Standard Compliance
We specialize in supporting medical device companies in developing AI management systems that meet regulatory, quality, and data-security requirements while ensuring compliance with industry regulations.
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ISO 42001 implementation guidance
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AI risk planning and support
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Review of support AIMS Gaps implementation
EU MDR and Global Regulatory Compliance
Our services help medical device companies align with regulatory standards, implement quality management systems, and navigate the complexities of global compliance requirements.
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Technical documentation & submission readiness review
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Post-market surveillance planning support
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Management Review & reporting
Regulatory Compliance Strategic Guidance
Our consulting services are tailored to meet the unique compliance needs of medical device manufacturers. From regulatory alignment to AI integration, we provide expert guidance and solutions to ensure compliance and help companies drive innovation.
