MedQR Consulting

Partner with us to break free from conventional approaches to regulatory compliance. Let us provide the alternatives that empower your growth and innovation. MedQR Consulting helps medical device companies succeed with high-quality Regulatory Affairs and Quality Assurance services. We ensure your products meet global standards efficiently and accurately. We specialize in: • Ensuring compliance with the European Medical Device Regulation (MDR) 2017/745 • Facilitating FDA approvals, including 510(k), De Novo, and PMA submissions • Facilitating UK market access and managing UKCA submissions • Handling global medical device registrations and preparing submission dossiers • Developing comprehensive technical documentation for EU MDR compliance • Conducting in-depth clinical evaluations and scientific reviews • Executing effective Post-Market Surveillance strategies • Expertise in biocompatibility according to ISO 10993 series • Managing cybersecurity requirements for medical devices • Regulatory support for combination devices Our quality assurance services include: • Implementing robust quality management systems per ISO 13485 • Establishing and maintaining MDSAP-compliant quality management systems • Conducting thorough audits in line with ISO 13485 and MDSAP • Streamlining CAPA management processes • Offering expert coaching and training on ISO 13485, MDSAP, and EU MDR standards Connect with us for expert guidance at [email protected]

• Employees 5
• Founded 2022