Quality and Regulatory Consulting
​A.P. Lyon helps medical device, manufacturing and food companies build practical quality and food safety systems, prepare for certification audits and FDA inspections, and validate their processes.
Quality System Installation and Training
Our customers benefit from the thousands of hours we have invested in quality system design and implementation. Whether supporting implementation of our quality system products or developing custom quality system procedures, our goal is to help customers focus on their products and services while providing the resources needed to achieve certification to ISO 13485, ISO 9001 or ISO 22000 / FSSC 22000, and FDA QMSR compliance for medical devices. Foreign medical device manufacturers can also use our FDA U.S. Agent and registration services.
FDA QMSR Inspection Readiness
FDA now inspects device manufacturers under the Quality Management System Regulation (QMSR), effective February 2, 2026, using the process in Compliance Program 7382.850, which replaced QSIT. We audit your critical systems the way an FDA investigator is likely to approach them under QMSR, then deliver a confidential report with a prioritized action plan. Preparation includes readiness training, a facility walkthrough, inspection-team roles and a documentation review, and we can support the corrective actions that follow.
Design and Process Validation
Whether developing a new product or process, you can leverage our validation products and resources to support your validation effort. Our experienced team can develop validation master plans, design and process validation protocols, manage the overall validation effort, and provide critical support through the final report.
ISO 9001 Certification Support
We help manufacturers and their suppliers implement or update an ISO 9001:2026 quality management system: a gap assessment against the 2026 edition, tailoring of our ISO 9001 documents or your existing procedures, internal audits, management review and preparation for the certification audit.
Food Safety Systems
We help food manufacturers and their suppliers implement an ISO 22000 or FSSC 22000 food safety management system aligned with FDA 21 CFR 117: tailoring the documentation to your site, structuring the hazard analysis and food safety plan records, internal audits and preparation for the certification audit.