How we can help you

• Regulatory strategy development. Our goal is to streamline the certification process and maximise your chances of successful CE-marking.
• Gap analysis and readiness assessment. We assess your readiness for MDR and IVDR compliance and provide actionable recommendations for improvement.
• Technical documentation preparation. We ensure that your documentation meets the EU regulatory requirements.
• Clinical and performance evaluation support. We offer support for clinical/performance evaluations, including literature reviews, data analysis, and preparation of clinical/performance evaluation reports.
• Risk management implementation. Our experts guide you in establishing a robust risk management system that meets the requirements of MDR and IVDR.
• Interaction with Notified Bodies. We manage communications and facilitate a smooth interaction to obtain the necessary approvals during the certification process.
• Post-market surveillance (PMS) guidance. We assist in setting up an effective post-market surveillance system to monitor your devices' performance after market launch ensuring ongoing compliance.
• Training and workshops. Our tailored training sessions and workshops equip your team with the knowledge and skills needed to maintain compliance.