We serve our expertise to help customers in the following areas of Regulatory compliance

1. Regulatory Compliance Risk

• Misalignment of interpretation of the MDR/IVDR requirements and Compliance Support for Medical and In-Vitro Diagnostics Devices.
• Uncertainty regarding MDR/IVDR requirements and infrastructure (e.g. EU UDI, EUDAMED, Test Laboratories)
• Technical File contents not compliant to EU IVDR/MDR
• Supporting data not available to support the Technical File update in a timely manner

2. Product Risk

• Shifting landscape of requirements since MDD/IVD may require additional product performance information
• Additional testing required for compliance
• Misinterpretation and unknown new requirements

3. Quality Risk

• Quality System (e.g. PMS, PMPF, RMP, CER, PER) is not compliant to new MDR/IVDR requirements)

4. Business Risk

• Business continuity for countries where CE marked products are sold or CE Mark is necessary to maintain the registrations outside of the EU
• Lack of timely guidance from regulatory authorities that leads uncertainty in the project