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A pioneering India-based manufacturer specializing in neurological balance technologies approached Freyr for expertise in navigating complex multi-regional regulations and securing quick market access across the EU, US, and India. Confronted with difficulties in aligning Quality Management Systems (QMS) with EU MDR, ISO 13485, and FDA standards, the client required a strong, risk-based Regulatory framework to ensure compliance and speed up product launch.
Explore this case study to see how Freyr rolled out a phased, agile QMS aligned with ISO 13485 and EU MDR, offered targeted training and workshops, and maintained inspection readiness, enabling quicker market access, increased investor confidence, and sustainable global growth.
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