SGS India: Trusted ISO 13485 Certification for Medical Devices

1. ISO 13485 certification services for medical devices Given the complex nature of the medical device industry, an effective Quality Management System (QMS) must be more technically driven and requires extensive documentation. BENEFITS OF MEDICAL DEVICE CERTIFICATION AND REGULATORY CHECK Strong QMS: Build a robust quality management system for consistent product quality and reduced legal and safety risks. EU compliance: Adhere to the QMS requirements of the new EU guidelines, becoming the recognized harmonized standard. Compliance: Demonstrate consistent adherence to customer and regulatory requirements in providing medical devices and related services. Certified trust: Gain certification from SGS, an accredited third party, and prove your commitment to meeting regulatory obligations. Credibility and trust: Establish yourself as a reputable and trustworthy provider in the highly regulated healthcare market. Competitive edge: Become more attractive to medical device manufacturers as a subcontractor. ISO 13485 is the QMS standard 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 ISO 13485 MDQMS? ISO 13485 is a Quality Management System (QMS) standard designed specifically for medical devices, derived from ISO 9001. It employs a process-based approach, ensuring quality and compliance at all stages of a medical device's life cycle. ISO 13485 is a minimum requirement for medical device manufacturers and at the core of numerous international market access programs, such as the Medical Device Single Audit Program (MDSAP), CE and UKCA marks. © SGS Société Générale de Surveillance SA (2023) – All rights reserved - SGS is a registered trademark of SGS Société Générale de Surveillance SA WHY CHOOSE ISO 13485 CERTIFICATION SERVICES FROM SGS? SGS offers comprehensive ISO 13485 certification services to guide you in the compliance journey: WHY IS REGULATORY COMPLIANCE REQUIRED FOR MEDICAL DEVICES? Understand the requirements through our internationally recognized 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. 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. Partnering with an experienced and trusted entity is essential for medical device manufacturers to smoothly navigate industry changes and comply with regulatory demands. MEDICAL DEVICES ACCREDITATIONS WE ARE NOTIFIED FOR: United Kingdom Accreditation Service (UKAS) National Accreditation Board for Certification Bodies (NABCB) Indian Certification of Medical Devices Scheme (ICMED) For further enquiries cbe.marketing@sgs.com +91-8655 907 419/ +91-7045 780 756 0 8069 388888 SGS.COM