Quality Assurance and Regulatory Affairs Outsourcing

A growing number of small to medium-sized medical device companies are realizing that using highly experienced third-party consultants or specialists, such as those individuals at Methodize Inc., to take care of regulatory and quality compliance saves time and money.

Due to the constant state of change within regulatory affairs of the medical device industry, it can be a difficult task for a company to get their product in compliance in today’s competitive market. When regulatory changes come through, they are often broad in scope and require a lot of attention and resources to fully understand and use appropriately. Methodize Inc. consultants have been dealing with the regulations for a long time, we have important connections and ties, and we have worked previously with the FDA and other regulatory agencies.

Also, Methodize Inc. can handle related work such as quality assurance, process/equipment validation, internal auditing management, complaint investigation and reporting, document control, design control and internal/supplier audits, and more.

Please contact us today to see how we can help your company navigate the world of regulations and quality system compliance.

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Important Changes Impacting Manufacturers of Products without an Intended Medical Purpose

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A Comprehensive Guide to Technical File and Design Dossier Development in the Medical Device Industry