Designed for companies that do not have a quality manager, we can manage your quality system for you at a significant cost reduction. This service provides our customers with peace of mind that the role of quality manager is being handled of by trained, qualified professional that is dedicated to your organization. This service includes, but is not limited to the following activities:

• Participation in management meetings
• Quality system training
• Internal audit
• Safety risk management activities
• Take part in code reviews
• Development and execution of design verification and validation activities
• Manage defect tracking
• Identification and implementation of process improvements
• Checklist and process preparation</li>
• Vendor assessments and surveillance
• Management of Complaint and CAPAs

Becoming compliant with current FDA regulations can often be a challenge for many companies. We understand the regulations and the guidance documents and can help apply this understanding to your quality system. Leveraging our past experiences with many other medical device manufacturers, we have been able to establish a complete suite of procedures and checklists that can be used to either build a new quality system, or improve an existing quality system.

Our certified lead auditors can assist in pre-audit preparation, conduct an internal audit, or help with corrective actions as a result of a 483 observation.

• Pre-audit preparation
• Post-audit response and corrective actions
• Updating and improving the quality system
• Setting up and streamlining new quality systems

Preparing for your ISO certification inspection or surveillance audit? Allow our certified lead auditors to assist you in preparing your organization for this event. We can assist you in finding and resolving potential observations before the audit so that the audit is conducted as quickly and smoothly as possible.

Part 11 compliance is often very misunderstood. We can help your organization identify where these concerns apply and where they do not. We can then assist your organization in the validation of these concerns using proven methods. Some of the key areas of concern that we can assist you are:

• Electronic Records
• Electronic Signatures
• Audit Trail

A 510(k) submission can be a very complex process that results in a large amount of documentation and often times delays from the FDA. We have completed quite a few submissions over the years and can use our lessons learned to help your organization. Let us show you how we can often times push forward the submission date by 30 to 60 days. We can also streamline the submission process so that we proactively address FDA concerns before the submission is provided to the agency, further reducing time from submission to clearance. Our proven processes and templates facilitate a fast and efficient 510(k) submission process.

We can also help your organization determine when a new submission is required, and if not how to process a non-filing justification.

Complaint, CAPA, and MDR (Medical Device Reporting) are three of the leading sources of 483 observations. Having a complete understanding of these processes, we can help your organization improve these processes so that they are all handled in a timely and efficient manor which reduces the risk of a 483 observation. These improvements can also improve customer satisfaction, and improve product safety and reliability.

Implementing a risk based approach to your validation effort is a key aspect of conducting your validation in a way that is not only cost effective, but also improves product quality and reliability. We can assist your organization in addressing these concerns, and help you focus your efforts on the elements of the validation effort that have a higher impact on product or process safety.

Need help identifying which applications you use require validation, or how exactly to conduct this validation? We can assist you in all aspects of this concern and help your organization become compliant.