US Agent Services
FDA US AGENT CASE STUDY CHALLENGE:A startup company in France successfully completed their US market clearance for an imaging device and selected a US distributor. After registering their manufacturing establishment in France with the FDA, the company became aware of the FDA’s requirement to appoint a US Agent. Their distributor was unwilling to take on […]
FDA Registration
FDA REGISTRATION CASE STUDY CHALLENGE:A small start-up company had achieved their second round of funding to commercialize custom dental surgical guides. The company manager had no prior experience in the medical device industry and very limited bandwidth. The company also had no supporting quality or regulatory resources. Facing the task of registering the product and […]
Training
TRAINING AlvaMed’s approach to training sets us apart from competitors. Our training is customized to the client’s needs and delivered by regulatory, quality and clinical consultants. Our trainers are true experts in their fields and each presentation is tailored to the organization and audience. Whether it’s a general training for all your staff or a […]
