The Regulatory supervision in medical devices and diagnostics industries is expanding as the regional health authorities and global regulators work to improve patient safety by minimizing the risk of device-related injuries and adverse events. To ensure the medical devices’ compliance beforehand, it is required that employees in all facilities at all levels are fully aware of, and adhere to, complete Regulatory compliance, gap analysis and remediation requirements.

Medical device manufacturers are dependent on Regulatory Affairs (RA) for scrutinizing everything from the Regulatory impact of medical devices compliance, gap analysis and remediation. Freyr’s expert Medical Device RA professionals assists organizations in ensuring Regulatory compliance, conducting gap analysis as per current requirements and finally handling remediation so as to obtain compliance successfully. 

Freyr Expertise

  • Quality management system
  • On-site assessments, reviews, and mock inspections
  • Internal communications process
  • Document control process, record keeping process and management review process
  • Set up operations, records and reports
  • SOP development/reviews and due-diligent reviews
  • Regulatory trainings
  • Design controls, DHF, DMR, DHR
  • Technical files/design dossiers
  • Preclinical and clinical Regulatory support
  • Shelf life, packaging and transport validations
  • Device testing requirements
  • Risk management
  • Usability engineering
  • Software validations, internal and external audits, and gap assessment
  • Global Regulatory submissions
  • Technical documentation, post-market surveillance and registration/approval process assistance
  • Assistance in obtaining Regulatory registrations
  • UDI, GDPR, EUDAMED compliance support
  • Clinical evaluation reports (CER)
  • MDR and IVDR Regulatory support

Freyr Advantages

  • Cost-effective
  • Global network with experienced medical devices Regulatory Affairs professionals
  • End-to-end medical devices and diagnostics Regulatory compliance service, gap analysis and remediation
  • Qualified team of experts with hands-on experience across all categories of medical devices and diagnostics
  • Support for region-specific Regulatory complexities, gap analysis and remediation
  • Extensive partner network across the world
  • Strong relationship with different Health Authorities, competent authorities, certification bodies, notified bodies and testing laboratories
  • Structured approach to ensure quick market access
  • RA professionals with global visibility and access to accurate, reliable and timely data to remain compliant and reduce risk for the manufactures, start-ups and OBLs
  • Centralized workflow management that tracks global product portfolios, providing a comprehensive view of product status
  • Capability to capture and track all Regulatory submission information, commitments, and tasks pertaining to new products and product life cycle management
  • Tracking and management of Regulatory compliance, gap analysis and remediation for all phases of the regulatory process, product life cycle, and submission process
  • Facilitates global compliance by reporting on registration status by country, product type, indication, dosage or any other classification, and integrates with document and change management, SOP tracking, and Regulatory auditing
  • Supports, manage and tracks Regulatory reporting, notifications and correspondences to fulfill Regulatory compliance, gap analysis and remediation