IVDR CE Marking Services

We are regulatory consultants play a crucial role in the IVDR CE Marking process and certification

• MDQMS – EN ISO 13485:2016/ BS ISO 13485:2016 implementation support
• ISO 14971 Risk Analysis Implementation and documentation
• Biological Evaluation plan and reporting
• Clinical and Performance Evaluation Guidance
• Usability Studies related to IVD equipments and tests kits
• Process Validations
• IVDR Technical Documentation
• Interaction with Notified Bodies

At CERT3Global, we offer end-to-end CE marking services tailored specifically for medical companies and manufacturers. Our expert team is dedicated to making the certification process as seamless and efficient as possible, allowing you to focus on innovation and patient care.

1. Initial Consultation and Regulatory Strategy

Our process begins with a detailed consultation to understand your medical device and its intended market. We conduct a thorough assessment to identify the applicable EU directives and regulations. Based on this assessment, we develop a customized regulatory strategy, outlining the steps required to achieve CE marking compliance.

2. Conformity Assessment Planning

Different medical devices require different conformity assessment procedures. Our team guides you through the appropriate route, whether it’s self-certification, conformity assessment with a Notified Body, or a combination of both. We help you prepare the necessary documentation, including the Declaration of Conformity, which asserts that your device meets all relevant EU requirements.

3. Technical Documentation and Quality Management

Creating comprehensive technical documentation is a cornerstone of the CE marking process. This includes detailed information about the device’s design, manufacturing processes, clinical evaluation, risk management, and post-market surveillance plans. Our experts assist in compiling and reviewing this documentation to ensure it meets all regulatory standards. We also support the implementation and maintenance of quality management systems (QMS) compliant with ISO 13485, which is essential for medical device manufacturers.

4. Clinical Evaluation and Risk Management

A critical component of CE marking for medical devices is demonstrating clinical safety and performance. We provide guidance on conducting clinical evaluations, including designing and executing clinical trials if necessary. Our team also assists in comprehensive risk management, identifying potential risks associated with the device and establishing mitigation strategies in accordance with ISO 14971.

5. Product Testing and Certification

To ensure compliance with EU standards, rigorous testing is often required. We coordinate with accredited laboratories and Notified Bodies to conduct the necessary tests, covering aspects such as biocompatibility, electromagnetic compatibility, and electrical safety. Our team manages the entire testing process, ensuring adherence to relevant standards and timely completion.

6. Post-Market Surveillance and Continuous Compliance

Achieving CE marking is an ongoing commitment. We provide support for post-market surveillance, helping you monitor your device’s performance and manage any regulatory updates or changes. Our services include assistance with periodic audits, product modifications, and re-certification, ensuring continuous compliance throughout your device’s lifecycle.

Outsourcing regulatory services for medical devices offers several benefits to manufacturers operating in London and parts of the United Kingdom.

Expert Guidance: Regulatory consulting firms such as CERT3 GLOBAL navigate complex regulatory landscapes, bringing extensive knowledge and experience in dealing with regulatory agencies, interpreting regulations, and ensuring compliance. This expertise can help manufacturers avoid mistakes and expedite the CE Mark certification process.

Cost Effectiveness: Hiring outside help for regulatory services can save money compared to training and employing in-house experts. By outsourcing regulatory activities to service providers like CERT3 GLOBAL, manufacturers can reduce the overhead costs associated with maintaining a full-time regulatory team.

– Streamlined Documentation: Outsourced companies take care of and update documentation consistently, ensuring compliance at all times.

– Focus on Core Activities:   Outsourcing regulatory services allows companies to focus on their core business activities while regulatory experts handle the complexities of MDR compliance. This can accelerate time-to-market for new products and reduce delays in regulatory approvals.

-Established Networks:   Regulatory consulting firms often have established networks and relationships with regulatory authorities, testing laboratories, and other key stakeholders. This access can facilitate smoother interactions with regulatory agencies and expedite the regulatory process.

– Overall Benefits: Outsourcing regulatory services for medical devices can help companies navigate the complex regulatory landscape more efficiently, reduce costs, mitigate risks, and accelerate market access, ultimately contributing to the success of their products and business ventures.