Medical Device Consulting Services
A.P. Lyon provides technical support during medical device design, development, manufacturing, regulatory approval, and global distribution. We help organizations build practical quality systems and prepare for regulatory requirements.
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 ISO 13485 certification and FDA quality system compliance.
FDA QSIT Audit Preparation
An FDA audit can be intimidating, but advanced planning and preparation can address critical areas of concern before the audit. We conduct audits of critical systems using techniques an FDA investigator is likely to follow. Our results are documented in a confidential audit report with an action plan. We can support implementation of necessary corrective actions. Audit-preparedness training, facility walkthroughs, audit-team identification, and documentation review are included in our preparation services.
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.