Medfiles USA offers comprehensive services covering the entire product life cycle of medical devices and in vitro diagnostic devices. Utilizing our expertise in product development projects to ensure that all regulatory requirements are taken into account from the beginning, our expert team provides guidance and assists with the preparation of required documentation for FDA submissions in US, CE marking processes in EU as well as product registrations in other countries including to PMDA in Japan. For requirements towards clinical evaluations and performance evaluations, quality management system implementation or maintenance, or even for products already on the market needing post-market surveillance and vigilance, such activities fit well within our prime scope of expertise.

Medfiles USA Service List:
Strategic Regulatory Development

  • Act as regulatory representatives or as independent reviewers to enhance device development projects
  • Provide device description and specifications, along with regulatory assessment and recommendations based on the current regulatory framework to create optimized regulatory strategy
  • Assist with determining intended purpose and product classification
  • Help clarify borderline issues to enable unambiguous product classification, support drug-device combination products, or navigate changes to product classification (e.g., drug à medical device)
  • Perform gap analysis between existing technical / design documentation and regulatory requirements (MDD/MDR, IVDD/IVDR)

Device Registrations

  • For 510(k) Premarket Notifications in US, complete guidance through the process from device classification to predicate device selection and on through to regulatory strategy consulting, evaluation and preparation of documentation
  • For FDA submission in US, support also available for Investigational Device Exemption Applications (IDEs), Premarket Approval Applications (PMAs), 513(g) Requests for Classifications, and de novo applications
  • For CE Marking in EU, guidance through the entire process from selection of suitable procedures for product conformity assessments to assistance with technical files / design dossiers through content planning, compilation of technical documentation and/or evaluation of existing documentation
  • For market expansion or other international product registrations, collation of country-specific product registration files
  • Maintenance activities for products already on the market

Quality Management

  • Providing ISO 13485 based QMS package or as needed consulting on requirements, establishment and implementation of QMS
  • Performing QMS (pre-)audits and gap analyses for compliance
  • SOP writing, review, and consultation

Post-Market Surveillance and Vigilance

  • Consultation on post-market surveillance, post-market clinical follow-up/performance follow-up and vigilance procedures
  • Coordination of post-market surveillance activities and performance of specific tasks related to PMS/PMCF/PMPF (e.g., systematic literature reviews, vigilance database searches)

Other Services

  • Tailored Device Trainings
  • Support/coaching for Quality/Regulatory Affairs personnel
  • Clinical Evaluations and Performance Evaluations