Regulatory Strategy
REGULATORY STRATEGY CASE STUDY CHALLENGE:A large international medical diagnostic system equipment manufacturer was beginning to see the fruits of a technology development collaboration with Boston-area medical research institutions. Having set up a subsidiary company in the US to commercialize these technologies, the company needed: APPROACH:AlvaMed proposed a project with: The 3-month, $60,000 project assessed the […]
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 […]
CANADA’S DEVELOPING ROLE IN THE MEDICAL DEVICE REGULATORY ARENA
Canada may not be one of the larger medical device markets on the global scene, but its regulatory structure is quite substantial. Its medical industry, consisting of mainly small to medium-sized organizations, is rooted in a solid regulatory foundation that has matured over time. While their first medical device structure was implemented under Canada’s Food and Drugs […]
EXCEL SPREADSHEET REQUIREMENTS AND VALIDATION PROCESS
Under 21 CFR 11.10 Controls for closed systems, all spreadsheets that are used to facilitate the product and/or quality system decision-making processes need to be within compliance, including requirements for validation, accurate copies and protection of records, limited system access to authorized individuals, audit trails, authority, operational and device checks, training, electronic signatures, and change […]
DO NOTIFIED BODIES HAVE THE CAPACITY TO MANAGE THE MDR AND IVDR TRANSITIONS?
While recent information shows that both Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) applications have been on the rise, there are concerns as to whether the Notified Bodies have the capacity and competency to accommodate this trend. In March of this year, the EU commission released Regulation (EU) 2023/607, with immediate effect. […]
