Services Available
| Perform independent audits to: – U.S. FDA Title 21 CFR Part 820 – FDA Quality System Inspection Technique (QSIT) – ISO 13485:2016 – ISO 9001:2015 – Medical Device Directives & EU MDR |
| Perform quality systems gap analysis and provide recommendations for improvement. |
| Provide auditor and audit program management training. |
| Plan and perform mock-FDA inspection audits. |
Success Stories
Ron worked with a major medical device company who, over the course of three years, received several FDA Form 483 observations (violations of the Food, Drug and Cosmetic (FD&C) Act). On this project, Ron was able to recommend improvements to the organization, which were accepted and implemented, to correct all non-compliance issues.
Over the course of 30 years, Ron, in various quality engineering, assurance and management positions, has led efforts to successfully establish and maintain several medical device quality management systems. These systems enabled the development, manufacture and service of in vitro diagnostic chemistry systems, radiological detector systems, and interventional devices.
Are Internal Auditors Really Independent?
While an organization’s auditing group may be independent of a function to be audited within the company, it remains a part of the same corporate quality system, rendering it susceptible to systems issues that may exist. Additionally, corporate cultural biases may make it difficult to obtain a truly independent examination of the organization’s quality management systems, regardless of its size.
True Independence
Utilizing the services of an external auditor will provide a totally independent examination of the organization’s quality management system. An experienced auditor, especially one who is a trained ISO 13485:2016 lead auditor and experienced with FDA medical device regulations, will be able to identify “weak links” in the organization’s system, that, if left unattended, may cause product safety, effectiveness and performance problems as well as regulatory non-compliance issues down the road.
Audits as a Learning Tool
Auditing as a service can provide various benefits and results:
- Auditing, by the book, against the organization’s documented quality management system, resulting in documented nonconformities and opportunities for improvement.
- Performing more extensive quality systems gap analysis to identify not only compliance issues, but providing recommendations to improve its effectiveness.
