CE Marking

CE Marking and timely registration in other countries and worldwide markets.

FDA Submissions and Reviews

Contract services, drug and medical device submissions, post-approval issues and local agency services.

ISO Consulting

ISO 13485 / ISO 9001 consulting and additional quality auditing, marking and control.

  • Establishment of an FDA registration for medical devices
  • Evaluation of your device and its materials for biocompatibility compliance
  • Planning and execution of biocompatibility studies according to ISO 10993-1
  • Preparation of clinical evaluations
  • Preparation of risk analysis management files (ISO 14971)
  • ETO / Gamma sterilization validation
  • Shelf life testing, including accelerated aging
  • Post-market surveillance planning and reporting
  • Establishment and implementation of a quality management system
  • Issuing and maintaining the quality manual and quality procedures
  • Establishment of MRB, CAPA, Training, Labeling, Document Control and Internal Audit systems
  • Validation of clean rooms, sterilization, packaging & transportation
  • Gap Analysis - assessment of your existing compliance with the current applicable requirements
  • Internal audits - Essential to continuously improve your process and essential for full regulatory compliance
  • Subcontractor / Supplier Audit - Audits of critical subcontractors & crucial suppliers are vital to your Quality Management System
  • CE Pre-Audit - With a CE Pre-Audit we guide you through the audit process before the official audit by the Notified Body
  • Support during an unannounced audit by Notified Body