MethodSense is a leading global life science consulting firm, providing services and solutions in regulatory strategy, quality assurance, technology and operations. Supported by LuminLogic, MethodSense’s custom-designed regulatory compliant information management software, we help clients maintain compliance throughout the lifecycle of their business, from product design and development through FDA clearance or CE marking and post-market activities.
Combining our experience and skills across the medical device sector, MethodSense works at the intersection of engineering and quality to help clients meet compliance requirements, improve their performance and create sustainable value for their stakeholders. With services that include regulatory strategies, software validation, human factors and usability engineering, risk management and quality compliance, MethodSense delivers breakthroughs.
Company’s Keywords:
fda compliance strategies, quality system development, process, validation strategies, compliance audits, software design control evaluations, risk remediation, gxp, 21 cfr part 11, iso, hipaa, cmm expertise
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