GMP and CE Certification
GMP AND CE CERTIFICATION CASE STUDY CHALLENGE:A major pharma company purchased a medical device business, seeking to achieve FDA clearance, CE certification and remain compliant under GMP regulations. APPROACH:An experienced AlvaMed team developed a project plan consistent with ISO 13485 and the European Union regulations. AlvaMed’s team: RESULTS:Risk analyses and a 510(k) draft were completed […]
Large Company QMS Harmonization
LARGE COMPANY QMS HARMONIZATION CASE STUDY CHALLENGE:One of the world’s largest life science companies was experiencing a significant increase in scrutiny from the FDA. At a time when the FDA’s increased expectations of QMS harmonization within large integrated life science companies had increased, multiple audits highlighted the need for harmonization across the company’s groups. The […]
Due Diligence
DUE DILIGENCE CASE STUDY CHALLENGE:A large multi-national pharmaceutical company determined that the best strategy for a major pain-relief product was to expand associated synergistic product offerings. One product was a medical device from a small device company whose device applied a magnetic field with claims to alleviate pain and reduce inflammation. While targeting the device […]
Design Control Document Templates
DESIGN CONTROL DOCUMENT TEMPLATES CASE STUDY CHALLENGE:A medium-sized manufacturer of invasive therapeutic products wanted an improved design control process that could function well with both disposables and systems. APPROACH:AlvaMed developed an approach that made use of detailed, self-tutoring templates for all DHF document types. RESULTS:The templates have been successfully used to provide a thorough and […]
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 […]
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) […]
