We provide tailor-made regulatory and quality services to ensure your vigilance and post-market processes are fully compliant with MDR, IVDR and ISO 13485:2016 standards, including the following:

• Compliance with guidelines and legislation – ensuring adherence to EU MDR regulatory requirements from A to Z.
• Person Responsible for Regulatory Compliance (PRRC) – supporting your internal or external PRRC role with expert guidance.
• Establishing a quality system and training of personnel – integrating vigilance into your QMS and training your team to execute processes confidently.
• Post-market surveillance system – crafting structured systems that proactively collect and assess post-market safety data.
• Assessment of incidents and events – evaluation of device-related events to determine significance and regulatory duty.
• Reporting of incidents and other events – preparation and submission of mandatory reports to competent authorities and Notified Bodies.
• Preparation and reporting of Field Safety Corrective Action (FSCA) – end-to-end management of corrective actions when safety issues arise.
• Preparation of Field Safety Notice (FSN) – drafting effective FSNs and coordinating stakeholder communication.
• Preparation of Periodic Safety Update Reports (PSUR) – expert support for regulatory reporting cycles.
• Setting up appropriate contractual arrangements and supervision – ensuring contractual clarity and oversight across your supply chain and partners.
• Audits and pre-inspection consultations – preparing you for regulatory scrutiny and market challenges.

These services are designed to help you build a compliant, resilient medical device vigilance framework that enhances both regulatory performance and operational excellence.