What is ISO 13485:2016?
ISO 13485:2016 is the international standard for a Quality Management System (QMS) specific to the medical device industry. Published in March 2016, this standard aligns with global regulatory requirements and supports the consistent design, development, production, installation, and servicing of medical devices.Based on the ISO 9001 framework, ISO 13485 includes additional requirements tailored to the safety, reliability, and effectiveness of medical devices. It applies to manufacturers, suppliers, and other organizations involved in the medical device life cycle.By implementing ISO 13485, companies can reduce risks, improve product quality, and demonstrate compliance with international regulatory standards—making it an essential certification for medical device organizations operating in a global market.
TSI Certification
Regulatory Compliance
Meet legal and regulatory requirements across different markets, including EU MDR, FDA, and others.
Trusted Quality and Safety
Demonstrate your commitment to product safety, reliability, and customer satisfaction.
Structured Management and Monitoring
Support effective planning, control, auditing, review, and continuous improvement of your QMS.
Access to International Markets
Enhance your eligibility for global partnerships and tenders.
- Benefits
Benefits of Implementing ISO 13485:2016
Improved Efficiency and Risk Management
Streamlined processes help reduce unexpected failures and operational risks.
Competitive Advantage in the Global Market
Gain international recognition with a trusted, third-party certification.
Why ISO 13485:2016 Matters
In the medical device industry, quality is not optional—it’s a requirement. ISO 13485:2016 ensures your organization meets rigorous international standards, enabling safe, effective, and consistent product performance while maintaining regulatory trust.
Certification Audits
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