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We are a trusted provider of regulatory and quality consulting services for medical device manufacturers. Our team of experienced experts is dedicated to helping you navigate the complex landscape of medical device regulations and quality management systems, so you can bring safe and effective products to market with confidence.
PRRC service: Interdos can deliver a PRRC person for your company! It is possible to delegate the PRRC role externally although there is an important condition attached. In order to outsource the PRRC position for your company, your device company must have less than 50 full-time employees and global sales totaling less than €10 million. If your company meets these criteria, you are exempt from the requirement that the PRRC must be an employee of your organization. Instead, you have the option to outsource this role to a third-party firm, like Interdos. However, it's crucial to bear in mind that the regulations still specify that this individual must be at your disposal on a permanent and continuous basis. Considering the gravity of their responsibilities, they should be integrated into your company in a manner that enables them to carry out their duties as if they were an actual employee.
Regulatory Consulting: Our regulatory consulting services are designed to assist you in understanding and complying with the ever-changing regulatory requirements for medical devices. From product classification and labeling to preparing and submitting regulatory submissions, our team will work closely with you to ensure your products meet all applicable regulations and standards, including Self-certification of Medical Devices and Drug device combinations as Class I under the MDR.
Quality Systems Consulting: Building and maintaining a robust quality management system (QMS) is crucial for medical device manufacturers. Our quality systems consulting services can help you develop, implement, and improve your QMS based on international standards such as ISO 13485. We provide customized solutions tailored to your unique needs, helping you establish effective quality processes and procedures throughout your organization.
ISO 13485 Gap-Analysis: Our ISO 13485 gap-analysis service helps you identify areas where your current quality management system may fall short of meeting the requirements of the ISO 13485 standard. Our experts will conduct a comprehensive assessment of your system and provide you with a detailed report outlining the gaps and recommendations for improvement, helping you ensure compliance with this critical standard.
ISO 13485 Audits: As an accredited ISO 13485 certification body, we can conduct internal audits of your quality management system to assess its effectiveness and compliance with the ISO 13485 standard. Our auditors have extensive experience in the medical device industry and can provide valuable insights and recommendations for enhancing your QMS.
Compilation of CE Product Dossiers: If you are seeking to place medical devices on the European market, compliance with the CE Marking requirements is mandatory. Our experts can compile comprehensive CE product dossiers that include all the necessary documentation and technical information, ensuring your products meet the requirements of the relevant European directives and regulations.
Contact Us: If you are in need of regulatory and quality consulting services for your medical devices, we are here to help. Contact us today to discuss your needs and learn how our expertise can benefit your organization.