Effectively tracking and updating a device’s design history, especially changes following regulatory approval, takes time and attention. Companies routinely make changes to products following commercial release and the ability to clearly track how these changes were implemented and documented is critical to being able to demonstrate continued regulatory compliance and inspection readiness. Requirements differences between markets adds to the complexity. AlvaMed’s knowledge of current regulations and industry best practices can help ensure your design documents are maintained as state of the art.
Determining the compliance status of design documentation for all devices.
Gathering technical information pertaining to the device design and changes, as well as current regulatory needs.
Methodically apply any updated requirements from user or patient feedback, testing, quality and regulatory requirements, and internal documentation.
Provide updates to governmental and/or regulatory bodies where necessary.
Ensure the files are ‘living’ documents and are stored and retained in accordance with the required periods.
AlvaMed’s dedication to quality and compliance is truly commendable. Their prompt and transparent actions in addressing the DHF audit findings showcase their commitment to excellence. What stands out to me is their meticulous gap assessment and proactive approach to risk management, which clearly illustrates their commitment to continuous improvement. I’m confident in their ability to maintain these high standards and look forward to continued collaboration.
Anika
Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
MedTech Client
It’s 75 degrees and sunny and I’m on my front porch thinking back on all the great work that has been done over the last six months. I feel quite fortunate to have found such a great team to work with in AlvaMed. We seriously could not have done this without you. This has been one of the most challenging projects I have ever been involved with. Looking back, I feel AlvaMed was the perfect choice.
Pfizer
This is a constant concern for companies, as regulatory requirements can be vague and vary depending on device classification and intended use. Companies often seek guidance on how much information is enough to demonstrate compliance without creating an unnecessarily cumbersome file.
Maintaining design documentation is an ongoing process, not a one-time effort. Companies need effective systems and procedures to manage document versions, incorporate new data, and ensure updated files are readily available for regulatory audits or market surveillance requests.
Companies often underestimate the risks of inaccurate or incomplete design documentation. Potential consequences include delays in market approval, product recalls, fines, and damage to brand reputation. Understanding these risks can incentivize companies to invest in proper design documentation maintenance.
Ready to learn more about how AlvaMed can help you ensure your design documentation is maintained and current
Schedule time to meet with Jon Saltonstall. Jon and his team combine deep knowledge of regulatory requirements with years of practical industry experience to help clients maintain their design documentation as state of the art.
