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. […]
MDR Compliance
A small medical device company facing limited resources successfully updated their QMS and achieved MDR compliance with AlvaMed’s expert guidance and efficient tools.
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 […]
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 […]
Jeff Cyr
We want to acknowledge the exceptional regulatory support provided by AlvaMed, particularly in our 510(k) submission process. AlvaMed’s expert guidance, meticulous attention to detail, and unwavering commitment to compliance were pivotal in securing the successful clearance of our medical device. Their knowledge and dedication streamlined what could have been a daunting process, and we are […]
Mira Leiwant
We want to express our sincere appreciation for AlvaMed’s outstanding support throughout our MDSAP and CAPA project. With AlvaMed by our side, we not only achieved regulatory adherence but also fortified our quality management systems. AlvaMed’s partnership has been transformative, and we recommend their services to anyone seeking a smooth pathway through the medical device […]
Bob Strasser
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 […]
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 […]
