EU MDR & ISO 13485 certification services for medical devices

1. EU MDR & ISO 13485 certification services for medical devices BENEFITS OF MEDICAL DEVICE CERTIFICATION AND REGULATORY CHECK Given the complex nature of the medical device industry, an effective Quality Management System (QMS) must be more technically driven and requires extensive documentation. Expertise in MDR requirements: Navigate the complexities of MDR compliance confidently with SGS. We specialize in various device classes, ensuring your products meet stringent standards. ISO 13485, UKCA, and MDSAP certification: Achieve certification for EU MDR & ISO 13485 with SGS. Our comprehensive services guarantee compliance and market access. Integrated audit solutions: Save time and resources with our integrated audit solutions. We streamline the certification process, helping you achieve compliance efficiently. Dedicated account management: Receive personalized support from our dedicated account management team. We tailor our services to meet your specific needs, ensuring a smooth certification process. Global resources, local understanding: Benefit from our global presence and local market understanding. Our experts speak the language and understand the culture, providing you with unparalleled support. EU MDR & ISO 13485 are the QMS standards that provides medical device manufacturers with a framework to demonstrate that they consistently meet customer and regulatory requirements and are committed to quality and patient safety. WHAT IS EU MDR AND ISO 13485? The EU MDR 2017/745 and ISO 13485 are critical standards for the medical device industry. The MDR ensures that medical devices meet stringent safety and performance requirements, while ISO 13485 establishes a framework for quality management systems (QMS). Transition to EU MDR The EU MDR 2017/745 came into effect in May 2021, replacing the Medical Device Directive (MDD). It provides a stronger, more transparent framework aligning with technical advances, medical science changes, and legislative progress. The transition period has been extended for some devices until 2028. It's crucial to certify to the new MDR requirements to continue selling in the European market. © SGS Société Générale de Surveillance SA (2023) –All rights reserved - SGS is a registered trademark of SGS Société Générale de Surveillance SA WHY CHOOSE EU MDR & ISO 13485 CERTIFICATION SERVICES FROM SGS? SGS offers comprehensive EU MDR & ISO 13485 certification services to guide you in the compliance journey: Updated timelines of EU MDR transition Regulation (EU) 2023/607, released on 15th March 2023, provides extended timelines for certifying medical devices under the new MDR. The transition period extension is subject to conditions ensuring product safety and manufacturers' steps towards MDR compliance. Understand the requirements through our internationally recognized EU MDR & ISO 13485 training courses. Confirm that your medical device products meet the requirements of the standard. Provide proof of compliance with our independent assessment and certification. Gain the quality assurance required to meet the demands of stakeholders at every level. WHY IS REGULATORY COMPLIANCE REQUIRED FOR MEDICAL DEVICES? MEDICAL DEVICES ACCREDITATIONS WE ARE NOTIFIED FOR: Regulatory compliance is not only a prerequisite for selling products but also an asset for medical device manufacturing company, helping it to adapt to business changes, improve efficiencies, improve supply chain traceability, showcase reliability, and distinguish itself from its competitors. United Kingdom Accreditation Service (UKAS) National Accreditation Board for Certification Bodies (NABCB) Indian Certification of Medical Devices Scheme (ICMED) Partnering with an experienced and trusted entity is essential for medical device manufacturers to smoothly navigate industry changes and comply with regulatory demands. For further enquiries cbe.marketing@sgs.com +91-8655 907 419/ +91-7045 780 756 0 8069 388888 SGS.COM