Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
The most informative process for any medical device manufacturer is that of feedback. Post-market feedback provides manufacturers with vital information pertaining to their product and their brand. While often only focused on problems, such as complaints, much can also be gained from proactively seeking feedback from positive sources as well. Implementing an effective process to mine and manage all feedback data is paramount to an organization’s success.
Define the type and extent of the surveillance needed.
Set clear goals to be achieved by the surveillance system.
Outline the personnel to be involved and their roles in carrying out the process steps.
Define the types of data to be gathered and the methods for analyzing them.
Assess the risks related to the data collected and implement actions where necessary.
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
AlvaMed exceeded expectations, showcasing remarkable depth, impressive competency, and extensive knowledge. Collaborating with AlvaMed was an absolute pleasure. The information they provided, particularly their regulatory support for convenience kits, was not only accurate but also highly valuable and practical. AseptiKits truly appreciates their exceptional assistance, and we’re already planning to engage AlvaMed’s services again in the near future.
CEO, Aseptikits
It is vital to ensuring the effectiveness of a quality management system, it is a valuable input to both risk management and design, and it is a source of understanding and achieving customer requirements.
While a complaint system is a major source of feedback, including a proactive approach by seeking out information prior to problems occurring offers a more well-rounded process.
The requirements for PMS should be established according to the risk associated with the device based on its intended use.
Schedule a meeting with Mark to discuss how AlvaMed can improve your post-market program management.
