Designing and implementing a risk-based QMS solution involves creating an efficient system and necessary compliance while not overshooting resulting in organizational slowdowns.
Our team at M.L. Reo Consulting offers a comprehensive or a la carte approach unique to your business to help you qualify or maintain your quality management system. Our quality management consultants have the experience and expertise required to help you every step of the way.
We aren’t satisfied with simply passing an audit. With over 50+ years of experience in the medical device field, we can create a fully customized, manageable, world-class QMS that raises your quality and compliance while reducing costs and errors.
Once you have your quality management system working at full potential, we can further aid you in the operations, regulatory affairs, and design & development services for your medical device
Based on a proven track record, M.L. Reo Consulting is a competent and efficient quality management consulting firm.
We will focus on what is needed for the company’s phase of life or take your company to a full Quality Management System (QMS) and certification. Or, if you need a preliminary audit or gap analysis to challenge the system or fine holes, we’ll do that too.
We can set up entire Quality Management Systems (QMS), maybe just update your Risk Management System (RMS) for ISO 14971: 2019, or just a labeling system overhaul and validation. Our team has successfully done it all.
During the development process, we will ensure the product is appropriately documented per the standards and regulations while navigating industry nuances and correctly interpreting guidance.
We have successfully completed Quality Management System implementation, CAPAs, remediation, pre-audits, internal audits, regulatory body audits, certifications, and reviews.
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