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
