Medical Device Regulatory Consulting, 510(k), CRO, IDE, PMA

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Methodize Inc. is a regulatory affairs consulting firm based in Minneapolis, MN, which works with medical device and In-Vitro Diagnostics companies to help meet regulatory standards and maintain compliance. The company offers interim regulatory affairs staffing to work on client site and also carries out project work on their own premises.

Methodize Inc. provides services in areas such as pre-market assessment, protocol reviews, statistical strategies, sample size calculation, regulatory applications, IDE, 510(k) and PMA support, investigational site monitoring, data entry, statistical analysis, data management, final reports, investigational site audits, sponsor audits, medical device clinical research training in good clinical practices (GCP), clinical trials design, project management for clinical studies and more.

With over 35 years of combined Regulatory, Quality and Clinical services Methodize Inc. has been helping companies all over the world in bringing medical devices and In-Vitro Diagnostics products to market. Anyone can read the regulations; Methodize Inc. provides efficient and effective solutions.

Our services also ensure that post market compliance is maintained throughout labeling advice and compliance with the applicable regulations. Whether a company is pondering the most effective way of pursuing a regulatory submission, starting up a clinical trial, or it needs to meet a quality system regulation or international standard, Methodize Inc. has the experience to help.