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Medical devices

Medical devices
Pharma D&S is the ally you can trust to face together the challenges of a highly competitive market in an efficient, reliable and timely manner.

The Medical Devices sector with the entry into force of the new legislation European Union-Medical Device Regulation No. 745/2017 will be affected by significant changes.

The new legislation, among the major impacts, will entail a strengthening of the designation criteria, of the surveillance processes and the role of Notified Bodies, of the clinical evaluation criteria and clinical investigations.

Post-marketing surveillance will become a requirement, meaning that companies must have in place systems to support their surveillance: a quality management system, a risk management system, a vigilance system for reporting incidents to competent authorities and prompt corrective actions.

  • understand the requirements and the full implications of the MDR
  • perform a gap analysis of current issues, reviewing and assessing what companies will have to do to meet the requirements
  • create a detailed road map to help you meet the requirements, including assessment of feasibility, strategy, timelines and costs
  • establish a system of maintenance support to ensure full compliance
  • revise the available documentation according to the current regulations to apply for authorisation, preparation of the application, submission and follow-up
  • prepare and/or review labelling and promotional material
  • translate texts and labels from / to the following languages: Italian, English, Spanish, French, German
  • elaborate labels mock-ups 
  • establish contacts with Notified Body and/or Regulatory Authorities
  • perform post-marketing surveillance
  • Clinical Program Development
  • Clinical Trial Application
  • Health Authority/ agency Interaction
  • Clinical Operations
  • Pediatric Investigation Plan (PIP)
  • Scientific Writing
  • Statistical Services
  • Global Procedure Management