Specialized Consulting in Medical Devices
Magnus Xpertise acts as a reference in regulatory consulting for medical devices.
We work strategically and in an integrated way, transforming complex regulatory requirements into clear and efficient paths to the success of each project.
Our approach combines technical expertise, market insight, and agility, ensuring solutions that balance compliance, innovation, and competitiveness. Each challenge is treated uniquely, focusing on concrete and sustainable results.
With personalized service, our experience and knowledge provide clients with exceptional results and exceed expectations.
Our Services
Specialized Consulting
We offer specialized consulting services for medical devices and technical documentation, assisting in the preparation of your technical documents in accordance with current regulations and standards.
We offer a hands-on service, meaning that in addition to identifying applicable regulatory requirements, we participate in the preparation of technical documentation and accelerate the time-to-market of new products.
Registration and Certification
We offer specialized consulting services in certification and regulatory affairs for medical devices and healthcare products, with experience in preparing technical documentation and registration dossiers, as well as monitoring certification processes (Inmetro, Anatel, CE MDR, UL, among others) and registration with regulatory agencies (Anvisa, FDA, etc.). We work in an integrated manner, focusing on legal and regulatory compliance, technical excellence, and agility, to ensure that your products meet all applicable requirements and are approved efficiently and quickly.
Quality Management
We offer QMS Consulting services to prepare your organization, aligning its processes with national and international management standards, whether for certification purposes or process improvement.
Our consultants specialize in evaluating your company's areas to identify applicable regulatory requirements, indicating the best path for compliance aligned with your company's objectives and strategies.
Business Regularization
We offer company registration and regularization services with regulatory authorities for the medical devices sector, focusing on obtaining the Company Operating Authorization (AFE) from ANVISA and the Good Manufacturing Practices (GMP) Certificate, which are essential for manufacturing, importing, distributing, storing, and exporting.
We fully support the process, from drafting petitions and adapting internal procedures to assisting with inspections by the local Health Surveillance agency.
With a technical and risk-oriented approach, we accelerate approvals, eliminate non-conformities, and ensure legal and competitive operation in the Brazilian market.
Audit
We provide quality management system and regulatory compliance auditing services for medical devices, independently evaluating company processes, documents, and records to identify non-conformities, risks, and opportunities for improvement, based on applicable standards and regulations (such as ISO 13485, RDC 665/2022, MDSAP, among others), supporting the company in preparing for certifications, health authority inspections, and customer audits, as well as strengthening the robustness of the quality system and product safety.
Training and Courses
Our professional training and development service is designed to provide your team with essential knowledge in medical equipment, quality systems, and regulatory affairs. We offer customized on-demand programs with practical and theoretical components, both in-person and online, ensuring your organization achieves operational excellence and regulatory compliance.
Want to know more?
Contact us to schedule a free assessment of your engineering and consulting needs. Our dedicated team is ready to provide customized solutions and expert support at every stage of the process. We’re here to help turn your ideas into reality.