Clinical Trial and Post-Market Surveillance Complaint Investigations

EdgeOne Medical delivers rigorous complaint investigation services customized to your product and process. At both the clinical and commercial stages, the stakes for managing complaints are high. Our approach is tailored to help you maintain highest standards of patient safety and compliance

Your Trusted Partner for Complaint Investigations

The compliance burden dramatically increases once your product is in contact with patients, making timely and efficient complaint investigations critical.

Without a well-structured approach, issues can escalate quickly, leading to delays, non-compliance, or even delays in determining a product recall is necessary. Having a clearly defined plan in place is essential for maintaining both regulatory compliance and patient safety.

EdgeOne Medical partners with you to create a seamless device investigation process that’s designed for speed, accuracy, and precision. Our goal is to ensure every complaint is handled efficiently, minimizing disruptions and keeping your product on track.

Key Elements of Our Robust Complaint Investigation Process

  • Customized around Essential Drug Delivery Outputs
  • Executed in our QMS and integrated with your QMS and Complaint Handling Process
  • Engineering resources versed in handling and identification of drug delivery device issues
  • FDA registered and inspected testing laboratory
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Tailored Complaint Investigations for You and Your Device

EdgeOne Medical’s complaint investigation program is designed to balance the need for rapid handling of complaint investigations while addressing your products’ unique attributes and seamlessly integrating into your overarching complaint handling process

Unique Risk Based Attributes

The investigation process is designed leveraging the outputs of your device development program, including risk management activities and Essential Drug Delivery Outputs (EDDOs) as defined by the FDA. This approach ensures that the investigation targets high risk characteristics and focuses on attributes critical to achieving the intended performance and safety of the drug delivery system.

Seamless Integration

The investigation process is a component of the overall complaint handling process which starts with receiving the initial call and ends with deciding as to whether action is required. Our process is developed collaboratively with you and your quality team to ensure a seamless flow of information and data through your process, allowing you and your team to make decisions and act as efficiently as possible.

Rapid Turnaround

Knowing the sensitivity of handling complaints expeditiously, EdgeOne quickly deploys resources to process the investigation through our laboratory and deliver findings to you. With our in-house testing lab and advanced technical problem-solving capabilities, EdgeOne is ideally suited to own the investigation and bring insights your team needs to make decisions.

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The EdgeOne Medical Advantage

EdgeOne Medical brings a holistic knowledge of end-to-end product development to our clients with the know-how to expertly integrate essential information from your product DHF and QMS. Combined with our technical resources and qualified testing lab facilities, we are able to offer a truly comprehensive approach to act as a true extension of your team.

What Sets Our Program Apart

  • FDA registered and inspected testing labs
  • Hands-on expertise with array of drug delivery systems
  • Technical problem-solving skills and resources
  • Flexibility and rapid deployment of resources
  • Understanding regulations of complaint handling
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Ready to Bring Your Product to Market with Confidence?

Schedule a Consultation