RQMIS boasts a team of seasoned professionals well-versed in the intricacies of regulatory requirements. We can assist you in drafting, compiling, organizing, and optimizing your Technical Documentation, ensuring compliance with relevant regulations and standards.
Maria Duguine, Ph. D., EU/UK Consultant
A medical device notified body is an independent organization designated by regulatory authorities to assess the conformity of medical devices with applicable regulations and standards. In the European Union (EU), notified bodies are designated by the European commission and the national competent authorities of each member state. These competent authorities are responsible for overseeing medical device regulations and ensuring the conformity assessment of medical devices within their respective jurisdictions.
It's important to note that under the new EU medical device regulations (MDR and IVDR), the requirements for designation have become more stringent. Let experts in global regulatory laws help you navigate the ever-changing landscape that is medical device path to market.
RQMIS Support
Are you a medical device manufacturer looking for a reliable and experienced partner to navigate the complexities of the Notified Body process? Look no further! RQMIS is here to support and guide you every step of the way. Our service offering includes:
Technical Documentation Expertise
Notified Body Submissions
RQMIS understands the specific requirements of different notified bodies and can help tailor your submission to meet their expectations. Our experienced team will work closely with you to ensure that your submission is comprehensive, accurate, and aligned with the expectations of the notified body.
Audit Readiness
RQMIS offers comprehensive audit support services to help you proactively address any gaps in your quality management system. Our experts will guide you through the audit process, conducting internal audits, identifying potential areas of improvement, and providing valuable insights to ensure your organization is audit ready.
Regulatory Expertise
RQMIS prides itself on its in-depth knowledge of global regulatory requirements. Our regulatory experts will provide you with the latest insights, ensuring your product remains compliant with changing guidelines and regulations.
Tailored Solutions
Our services are tailored to meet your specific requirements, whether you are a start-up seeking initial regulatory compliance or an established company expanding into new markets. We offer flexible solutions that align with your goals and help you achieve regulatory success.
Partner with RQMIS today and benefit from our comprehensive notified body support services. Contact us now to learn more about how RQMIS can support your regulatory journey.
