Building and maintaining a quality management system to comply with the latest domestic and international regulations can be a daunting task, especially for small manufacturers or for those without the resources to staff quality system professionals.

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At Merrell & Company, we take great pride in working with each of our clients, regardless of size, to build strong, easy-to-follow quality management systems that are tailored to the specific requirements of each company.

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Specializing in the following disciplines, Merrell & Company offers a full range of services to meet your quality system needs:

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• CFR - Code of Federal Regulations 21 CFR Part 820 (Quality System Regulation)

• Medical Device Single Audit Program ("MDSAP")

• ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes)

• ISO 9001:2015 (Quality management systems. Requirements)

• ISO 17025:2017 (General requirements for the competence of testing and calibration laboratories).

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Whether you're just starting out and aren't sure where to begin, or have a quality system in place and are looking for ways to streamline and improve, Merrell & Company is here to help your company experience improvement through compliance.