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MethodSense Regulatory Consulting

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MethodSense is a regulatory and quality consulting firm for medical device companies. For more than 25 years we’ve helped device makers reach the US and European markets, with work in 38 countries and more than 1,000 regulatory and quality successes. Our consultants work on FDA 510(k) and De Novo submissions, EU MDR technical documentation and clinical evaluations, and the quality systems behind them, built to ISO 13485 and FDA’s QMSR. A typical engagement might be a regulatory roadmap for a device still in development, or an EU MDR gap assessment for a product already sold under the MDD. We also build LuminLogic®, an AI-enabled eQMS and compliance platform for MedTech teams. It puts the regulatory knowledge our consultants use into the software quality and regulatory teams work in every day: document control, change control, CAPA, audits and training, all traceable in one place.

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