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 […]
MANAGING CHANGES AND MAINTAINING COMPLIANCE
Under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), devices need to meet the applicable “harmonized standards” to demonstrate conformity with the essential requirements. If a harmonized standard referenced in the technical documentation (including the DHF) is updated, manufacturers are expected to assess the impact and incorporate any necessary changes […]
FDA ISSUES GUIDANCE CONTENT OF PREMARKET SUBMISSIONS FOR DEVICE SOFTWARE FUNCTIONS
The FDA released new guidance for the Content of Premarket Submissions for Device Software Functions [1] in June 2023. This guidance replaces the preexisting guidance from May of 2005. Since then, technological advances have caused software to become an important part of medical devices. The final guidance moved to a simplified risk-based approach to determine […]
FDA ESTAR OVERVIEW
Currently, all medical device submissions for 510(k), De Novo, and Pre-Submissions may voluntarily use eSTAR. The intention of the program is to enhance the quality of submissions by providing a standardized format so submitters can ensure submissions are complete. Additionally, the review process can be streamlined and more efficient. Starting October 1, 2023, all 510(k) […]
