Services Available
| Review Technical Files and regulatory submissions for compliance to documented practices and regulatory requirements. |
| Review quality management system records for compliance to U.S. FDA and EU medical device and combination products regulations. |
| Lead management team efforts in the planning and execution of quality system registration and certification efforts. |
| Perform FDA remediation and corrective and preventive action activities. |
Success Stories
As a member of a sixteen (16) person U.S. FDA Quality Systems Regulation (QSR) remediation team, Ron led corrective action effort to bring into compliance supplier and purchasing controls of an international medical device company headquartered in Japan.
Ron has led and managed a successful U.S. FDA inspection of a medical device manufacturing organization, resulting in no FDA Form 483 observations. He has participated as a compliance team member on several additional FDA inspections.
Have all Required Regulations been Considered?
Depending on the numbers and types of quality system regulations that are required to be met, it is likely that there will be significant differences among them that must be addressed in the quality management system.
What ISO 13485:2016 Requires
Ensure that all applicable country, industry, government and international regulations and requirements are identified, understood and addressed in the organization’s quality management system. The integration of all applicable regulatory requirements is a requirement in the 2016 version of ISO 13485: “The organization shall document a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard and applicable regulatory requirements”.
Create a Matrix
A quality management system matrix is one of the best ways to present the relationships between regulatory requirements and documented organizational quality system processes. Depending on the number of regulations required to be met, an electronic database may be an effective way to manage these relationships.
