M.L. Reo Consulting

Quality Management System Consulting Services

We help you implement world-class quality management systems and maintain them.

Our Quality Management Consulting Services

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

Full Quality Management System (QMS)

We have created or modified many Quality Management Systems compliant with the FDA cGMP and ISO13485. The keys here are ease of use, efficiency, and compliance.

Quality System Fixes

Things go wrong...we have been there and can help investigate, identify, and remediate root causes. Quality Management System section revisions, Material Review Board (MRB), Corrective and Preventative Action (CAPA), Complaints, system fixes

Risk Management

In medical devices, this is the bulwark between patients, users, your company, and the downside. After multiple projects and commercially released medical devices, we know how to effectively implement a Risk Management System and keep issues to a minimum.

Corrective and Preventive Actions (CAPA)

CAPAs require thorough documentation. Sometimes organizations fall down on pencil whipping a CAPA to satisfy system requirements, but don't solve the problem. We have remediated many systems and specific problems conclusively. We know how to implement investigative techniques and solutions to resolve problems throughout the organization, products, and QMS, and then verify it is corrected.

Remediation Plans

Sometimes fixes require a highly structured resolution to avoid or minimize harm to the company's business and product. We can develop a plan that harmonizes with the organization's ongoing efforts and implement the plan maximizing efficiency and reducing organization impact.

Audits & Audit Support

Want to know where your QMS weak spots are located? Do you suspect there are areas or systems of noncompliance? We will investigate and identify gaps to any degree desired. We have done small system reviews such as the Risk Management System or Design Controls, and whole QMS audits in preparation for certification.

MLRC quickly implemented a gap analysis that saved Minerva Surgical time and resources allowing us to improve our system.

Dominique Filloux
COO @minvera Surgical

Your Quality Management Consulting Experts

Experienced QMS Consultants

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.

Comprehensive Quality Expertise

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. 

Need Quality Systems help?