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Welcome to Medical Device Regulatory Compliance (MDRC)

Your partner in providing expert consulting and services for medical device companies seeking CE-marking under the MDR and IVDR.

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The cornerstones of regulatory support

Expertise and Knowledge We provide in-depth knowledge of the relevant regulations and guidelines. Customised Solutions No one-size-fits-all approach. We tailor our solutions to meet the unique needs of each client. Comprehensive Services We offer a full range of services around the CE-marking for medical devices. Ongoing Partnership To us regulatory support is not a one-time engagement; it is an ongoing partnership.

By having these four cornerstones in place, we provide medical device companies with the necessary guidance, expertise, and assistance.

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.

Our services

1. Technical documentation

  • Device description and specifications
  • Information supplied by manufacturer
  • Design and manufacturing
  • GSPR and applicable standards
  • Risk management
  • Product verification and validation
  • Post-market surveillance

2. Quality management system

  • Gap Analysis
  • Regulatory Compliance
  • Quality Policy and Objectives
  • Documentation
  • Process Mapping
  • Risk Management Integration
  • Training and Competence
  • Internal Auditing
  • Management Review
  • Continuous Improvement

3. Clinical / performance evaluation

  • Literature Review
  • Clinical Data Collection
  • Risk Assessment
  • Clinical Investigation Planning
  • Clinical Evaluation Report (CER) Development
  • Updating the Clinical Evaluation
  • Expert Consultation

4. Risk management system

  • Risk Identification
  • Risk Assessment
  • Risk Analysis
  • Risk Control Measures
  • Risk Management Plan
  • Risk Management Report
  • Risk Management File
  • Risk Management Review
  • Training and Implementation

5. Communication with Notified Bodies

  • Submission Management
  • Interaction Facilitation
  • Regulatory Compliance
  • Timely Follow-Up
  • Issue Resolution
  • Audit Support
  • Updates on Regulatory Changes
  • Maintaining Communication Records
  • Post-Certification Support

6. EU Authorised Representative

  • Legal Representation
  • Registration and Designation
  • Regulatory Compliance
  • Communication with Competent Authorities
  • Quality Management System Review
  • Documentation Management
  • Post-Market Surveillance
  • Regulatory Updates
  • Conformity Assessment

7. Person Responsible for Regulatory Compliance (PRRC)

  • Expert Consultation
  • Regulatory Compliance Oversight
  • Education and Training
  • Quality Management System Review
  • Technical Documentation Review
  • Post-Market Surveillance Oversight
  • Interaction with Competent Authorities
  • Audit Support
  • Maintaining Compliance Records
  • Updating on Regulatory Changes

Long-term success

We are committed to fostering long-term partnerships with our clients, providing ongoing support and staying by your side even after CE-marking has been achieved.

Contact us now to start your journey towards regulatory success under the MDR and IVDR.

Send us an email:

Or use the contact form below