Joana Martins
Joana Martins is a Quality Assurance and Regulatory Affairs Specialist with over 10 years of experience in medical devices, quality management, and product development. She specialises in ISO 13485 quality management systems, FDA regulatory requirements, technical documentation, risk management, and post-market surveillance activities. Throughout her career in both industry and research, Joana has supported the development and regulatory compliance of innovative medical devices, helping manufacturers bring safe, compliant products to market.
Latest Articles
Regulatory Updates
FDA Regulation of In Vitro Diagnostic Devices: The Complete Guide for US Market Entry
Last Updated: 2026-08-10
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Regulatory Updates
ISO 20417:2026: Medical Device Labelling Changes and Compliance Gaps
Last Updated: 2026-08-10
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Blog & Insights
FDA QMSR Gap Analysis: Compliance Guide for IVD and CDx Manufacturers
Practical guide for medical device manufacturers explaining FDA QMSR changes, MDSAP alignment, inspections, and key compliance preparation steps.
Last Updated: 2026-08-10
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