EU SERVICES

• Strategic and regulatory planning

• Auditing of Regulatory systems to ensure compliance with required regulations

• Regulatory GAP Analysis

• Interpretation of guidance documents and legislation

• Assistance with device labelling requirements

• Liaison with Regulatory Authorities

• Provide medical device classification

• Risk Management (ISO 14971) review

• Regulatory and Technical review and consulting

• Preparation and submission of registration documents for product applications

• Regulatory and manufacturing compliance

• Company specific training