Directory of Quality
We were working on a very tight deadline to submit 483 responses to the FDA with extremely limited resources to get the job done. We hired AlvaMed to help us, and they were able to on-board, advise us on strategy, work with our team, and draft responses to our findings in less than 2 weeks. […]
Kelly Ashfield
We were in search of a consulting firm to assist us in tailoring our existing quality management system to meet our specific requirements. That’s when we engaged AlvaMed, and I must say, their performance was truly outstanding. AlvaMed swiftly grasped the intricacies of our unique needs and hurdles, crafting a bespoke solution that perfectly aligned […]
Angel Iglesias
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 […]
Erik Williams
I’d like to take a moment to express my gratitude for AlvaMed’s quick response, experience and professional approach to addressing our efforts to respond to an audit finding. AlvaMed conducted a comprehensive assessment of our product technical documentation, identified gaps related to current standards and regulations, and provided a clear definition of objectives and a […]
Charlie
We are extremely satisfied with the quality support services provided by AlvaMed. Their expertise in the medical device industry, tailored solutions, and transparent communication have been invaluable to our operations at Goddard Technologies, Inc. We highly recommend their services to anyone seeking top-notch quality support.
David Davilla
We are delighted to express our appreciation for the exceptional quality engineer support provided by AlvaMed. With AlvaMed’s guidance, we’ve not only met regulatory requirements but have also exceeded our own quality benchmarks. AlvaMed has proven to be a valuable partner in our pursuit of excellence, and we highly recommend their services to anyone seeking […]
Joe Dobkin
We are extremely pleased to share our experience with AlvaMed’s exceptional design assurance support. With AlvaMed’s guidance, we have not only met but exceeded our design assurance goals, resulting in safer and more innovative medical devices. AlvaMed has proven to be a trusted partner in our journey towards design excellence, and we recommend their services […]
Michael Pereira
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 […]
Mark Licari
I have relied very heavily on the AlvaMed Team since 2018. Working primarily with Diana and Jon, I rely on their inputs and thoughts frequently and I always trust their inputs. If there is doubt, they follow up in a timely manner. Much of our success is based on the relationship we have with all […]
Director of QA/RA
AlvaMed is a great partner for a small company like ours. Their invaluable support, including quality assurance consulting services at various levels in the organization have supported our Director of QA/RA without the need to hire additional people. Their expertise in bringing companies into compliance with the EU MDR and supporting notified body audits, has […]
