Welcome to Medical Device Regulatory Compliance (MDRC)

How we can help you

• Regulatory Strategy Development. We collaborate closely with your team to develop a customised regulatory strategy that aligns with your product's characteristics and intended market. Our goal is to streamline the certification process and maximise your chances of successful CE-marking.
• Gap Analysis and Readiness Assessment. We conduct gap analyses to identify any existing deficiencies in your technical documentation, quality management system, or clinical evaluation. We assess your readiness for MDR and IVDR compliance and provide actionable recommendations for improvement.
• Technical Documentation Preparation. We assist in the preparation and compilation of all necessary technical documentation required for CE-marking under MDR and IVDR. 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 act as your intermediary with Notified Bodies during the certification process, managing communications and facilitating a smooth interaction to obtain the necessary approvals.
• 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 and safety.
• Training and Workshops. Our tailored training sessions and workshops equip your team with the knowledge and skills needed to maintain compliance and successfully manage post-market activities.