Medical devices consultancy

Regulatory Affairs consulting is a strategic service that enables companies to plan and design market access for their medical devices.

Of no less importance is the quality management system, a fundamental element to successfully maintain its medical devices on the market. For this reason, the Medifocs consultation services bring together Regulatory Affairs and Quality Assurance activities in a unique system.

Regulatory Affairs

  • Designing Post-Market Surveillance (PMS) and Clinical Follow-up (PMCF)
  • Designing and conducting the Clinical Assessment process
  • Gap analysis for compliance with Regulation (EU) 2017/745 of “Legacy” medical devices
  • Design of regulatory strategies for medical device marking
  • Biological Risk Assessment and support for planning safety and efficacy tests
  • Support in preparing the risk management document according to the ISO 14971 standard
  • Preparation of technical documentation
  • Assistance with registration procedures for Economic Operators and medical devices
  • Regulatory Compliance Officer for Micro and Small Enterprises
  • Selection and qualification of the Notified Body
  • Support for FDA approvals

Quality Assurance

  • Implementation of quality management systems according to the ISO 13485 standard
  • Support in the preparation of system documentation
  • Quality Assurance Manager for micro and small enterprises
  • Supplier qualification
  • Gap Analysis and process optimisation
  • Process validation (non-special)
  • Assistance in planning, design and development
  • Support in the identification of processes and risks related to business processes
  • Selection and qualification of the Certification Body

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