Is ISO 13485 Certification right for your medical devices?

1. The Value of Regulatory Compliance in Healthcare Is ISO 13485 Certification right for your medical devices? 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. This standard is crucial for organizations involved in medical device design, development, installation, and services. Additionally, it forms the foundation of the Medical Device Single Audit Program (MDSAP). 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, proving your commitment to meeting regulatory obligations. Build 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. Why medical devices regulatory compliance? Experienced Partner: When manufacturing medical devices, partnering with an experienced and trusted entity is essential to navigate industry changes and regulatory demands. Asset for Your Company: Regulatory compliance is not only a prerequisite for selling products but also an asset for your company, helping you adapt to business changes, showcase reliability, and distinguish from competitors. Why choose ISO 13485 certification services from SGS? SGS offers comprehensive ISO 13485 certification services to guide you in the compliance journey: Key benefits of regulatory compliance: Understand Requirements: Through internationally recognized ISO 13485 training courses. Product Confirmation: Ensure your medical device products meet the standard requirements. Independent Assessment: Provide proof of compliance with SGS's independent assessment and certification. Quality Assurance: Gain the necessary quality assurance to meet stakeholder demands at every level. Enhance Credibility: Increase customer trust and confidence in your products. Assure Quality: Validate the consistency of production or service. Improve Efficiencies: Enhance processes and operational efficiencies. Manage Risks: Provide proof of due diligence and compliance, managing risks effectively. Save Resources: Save time and money through streamlined processes. Market Access: Increase opportunities and market access, gaining a competitive advantage. Adaptability: Keep up with the ever-changing regulatory environment. Traceability: Reduce fake devices and improve supply chain traceability, enhancing patient safety and treatment. For further inquiries cbe.marketing@sgs.com +91-8655 907 419/ +91-7045 780 756 0 8069 388888