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Maria Duguine, Ph. D., EU/UK Consultant
Software as a Medical Device (SaMD) has transformed healthcare, but complying with the intricate regulations in the EU and UK can be challenging. RQMIS offers expert guidance to ensure compliance and streamline market entry. Our services include developing regulatory strategies, assisting with submissions and compliance, establishing quality management systems, and supporting clinical evaluation and post-market surveillance. RQMIS helps SaMD manufacturers navigate the regulatory landscape, enabling them to focus on delivering innovative solutions that enhance patient care.
Software as a Medical Device (SaMD) has revolutionized healthcare, offering innovative solutions for diagnosis, treatment, and patient care. However, navigating the intricate regulatory landscape governing SaMD in the European Union (EU) and the United Kingdom (UK) can be a daunting task. That's where RQMIS comes in, providing expert guidance and support to ensure compliance with regulations and to streamline market entry.
Regulatory Strategy Development
RQMIS specializes in helping SaMD manufacturers develop a strategic roadmap to navigate regulatory requirements successfully. By understanding the nuances of the EU Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and the UK Conformity Assessed (UKCA) mark, RQMIS offers tailored guidance to pave the way for a successful market entry.
Regulatory Submissions and Compliance
Preparing and submitting regulatory documents is a crucial aspect of SaMD compliance. RQMIS assists SaMD manufacturers in compiling technical files, clinical evaluations, and conformity assessments to ensure adherence to the stringent EU MDR, IVDR, and UKCA requirements. With RQMIS by your side, you can streamline the submission process and stay on top of compliance obligations.
Quality Management Systems
Establishing robust quality management systems is essential for SaMD manufacturers to meet regulatory standards. RQMIS offers expertise in developing effective quality management systems that align with relevant regulations and standards. By implementing comprehensive quality processes, manufacturers can ensure their SaMD products consistently meet the highest standards of safety and performance.
Clinical Evaluation and Post-Market Surveillance
To ensure the ongoing safety and performance of SaMD products, RQMIS supports companies in conducting thorough clinical evaluations, post-market surveillance, and vigilance activities. These measures are essential for monitoring product effectiveness, identifying potential risks, and maintaining compliance with regulatory requirements. RQMIS provides the necessary expertise and support throughout these critical processes.
Compliance with SaMD regulations in the EU and UK is vital for manufacturers aiming to bring their innovative solutions to market. RQMIS serves as a trusted partner, offering a range of services tailored to the specific needs of SaMD manufacturers. From regulatory strategy development and submissions to quality management systems and post-market surveillance, RQMIS ensures a streamlined and efficient path to compliance. By collaborating with RQMIS, SaMD manufacturers can navigate the complex regulatory landscape with confidence, enabling them to focus on delivering impactful solutions that enhance patient care and revolutionize the healthcare industry.
Contact us today to find out more.