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.

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 […]

Regulatory Strategy

Client feedback rated AlvaMed’s work excellent and the results enabled the client to: Have the justification to go to the parent company’s management and request additional funding to accelerate two highly attractive technologies, maintain development funding for two other technologies, shelve the remaining technology.

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 […]


Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.

Gale Thorne

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 […]

Arta Doci

Working with AlvaMed was a pleasure. Their professionalism and extensive knowledge were truly commendable. What stood out was their comprehensive regulatory expertise, spanning across the US, Canada, and EU. AlvaMed’s guidance in formulating a regulatory plan for these regions was invaluable to our project. We are highly satisfied with their services and look forward to […]