From product development through commercialization and beyond, developing and maintaining a comprehensive risk management file helps make better products and ensures compliance with regulations. However, companies tend to find themselves getting behind keeping those files up to date. AlvaMed’s team of experienced product development engineers can help you identify gaps and bring your risk management file into compliance with the current version of ISO 14971.
We will review your current risk management file to identify gaps based upon current ISO 14971 and regulatory requirements.
We will help you develop a plan to update the necessary documents. We can provide compliant templates for common risk management tools if necessary.
We will work directly with your team to update each of the documents within your risk management file. Our support can range from reviewing your prepared drafts to hands-on updating of your files.
We can help you establish and maintain processes for periodic review and updating of the risk management file to ensure it always remains current.
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
RenovoRx had the opportunity of collaborating closely with AlvaMed on a critical project involving lot release and risk management updates. AlvaMed’s dedicated team has consistently gone above and beyond to ensure the success of this project. Thanks to AlvaMed’s support, we have not only achieved the necessary updates but have also enhanced the efficiency and quality of our manufacturing processes. Their expertise and collaborative approach make them a valued partner, and we highly recommend their services to anyone seeking support in medical device compliance.
RenovoRx
We were looking for a consulting company to help us with all areas of quality affairs: implementing our first QMS, requirements development, risk management and design verification planning. AlvaMed has a pulse on the size of our company and capabilities and a good understanding of how to support our timelines and resources. AlvaMed right-sized our QMS by considering our internal and outsourced activities. AlvaMed’s experience was invaluable in anticipating needs before they became critical and stepped in as needed with varying levels of support. I would highly recommend AlvaMed to any medical device company.
MVS Surgical
Mark’s company AlvaMed is staffed with resources that can bring considerable experience to bear on problems that plague companies developing products in the medical device space. On one large program, we hired AlvaMed to analyze a collection of system specification deliverables to identify any missing, incomplete, or conflicting requirements. The AlvaMed team analyzed hundreds of pages of specifications and returned a detailed report within two weeks. Their quick turnaround and insightful comments allowed the development team to correct several requirement deficiencies and helped keep a critical milestone design review on track. Based on their outstanding combination of experience, responsiveness, and performance I would strongly recommend AlvaMed to medical device manufacturers who need help with product development or risk management issues.
Program Manager, Boston Scientific
Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
MedTech Client
ISO 14971:2019 is recognized by both the US FDA and EU Notified Bodies as the gold standard for performing medical device product risk management. All regulatory submissions are expected to comply with this standard.
It is potentially out of date if it was built following an older version of ISO 14971 and has not been updated since. Even newer files built following the current standard may be out of date if companies lack a formal process for periodic review.
AlvaMed’s experts have worked with many different product types and have seen many ways to comply with risk management requirements. This allows us to offer best practice guidance while ensuring requirements are being met.
Jon and his team of medical device engineers understand that preparing a good risk management file helps lead to improved product designs and fewer questions during regulatory submissions.
Are you ready to get your risk management files current with the latest standards and best practices?
Schedule time to meet with Jon Saltonstall. Let AlvaMed help you get your risk management files up to date before it’s too late.
