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Pengyoux
Pengyoux
Our Services

Medical Device Regulatory Services

PengyouX provides comprehensive regulatory consulting services to international enterprises aiming to gain approval for medical devices in the Gulf Cooperation Council (GCC) region. Our services are designed to navigate the complex regulatory landscape and ensure compliance with both regional and international standards. We assist in all aspects of regulatory approval, including managing relationships with authorized representatives and preparing Clinical Evaluation Reports (CERs).

Our Offerings

Regulatory Consultation:

  • Expert Guidance: We offer specialized advice on the regulatory requirements for medical devices within the GCC, helping clients understand and meet the necessary compliance standards.
  • Approval Process Navigation: We guide clients through the entire regulatory approval process, from initial submission to final authorization.

Authorized Representative Management:

  • Enterprise Liaison: We manage and facilitate relationships between international enterprises and their authorized representatives in the GCC, ensuring smooth communication and compliance.
  • Regulatory Representation: We act as an intermediary to ensure that regulatory requirements are met and that the enterprise’s interests are effectively represented.

Clinical Evaluation Report (CER) Support:

  • Preparation and Maintenance: We assist in the preparation and ongoing maintenance of Clinical Evaluation Reports (CERs) in accordance with both the current MEDDEV 2.7/1 Rev4 guidelines and the new Medical Device Regulation (MDR) standards.
  • Comprehensive Consulting: Our team provides detailed consulting support for all aspects of CERs, including data collection, analysis, and report writing to ensure that the CERs meet regulatory requirements and demonstrate the safety and efficacy of the medical devices.

Compliance with MEDDEV and MDR Standards:

  • MEDDEV 2.7/1 Rev4: We ensure that CERs are compliant with the MEDDEV 2.7/1 Rev4 standards, which outline the guidelines for clinical evaluations of medical devices in Europe.
  • MDR Compliance: We also ensure adherence to the new Medical Device Regulation (MDR) standards, which govern the regulatory framework for medical devices in the European Union and have implications for international markets.

Holistic Support:

  • End-to-End Service: From initial regulatory consultation to the final approval, we provide end-to-end support to ensure that all regulatory requirements are met and that the approval process is efficient and effective.
  • Client-Centric Approach: We tailor our services to meet the specific needs of each client, providing personalized support and solutions to address unique challenges and requirements.