Ensure Medical Device Quality and Compliance with ISO 13485:2016
ISO 13485:2016 is the globally recognized standard for Quality Management Systems (QMS) specific to the medical device industry. It helps organizations demonstrate consistent design, development, production, installation, and delivery of medical devices that meet both customer and regulatory requirements.
At EWOCS, we provide ISO 13485 certification to empower manufacturers, suppliers, and service providers to improve product quality, enhance risk management, and ensure patient safety in a highly regulated industry.
ISO 13485:2016 is the globally recognized standard for Quality Management Systems (QMS) specific to the medical device industry. It helps organizations demonstrate consistent design, development, production, installation, and delivery of medical devices that meet both customer and regulatory requirements.
At EWOCS, we provide ISO 13485 certification to empower manufacturers, suppliers, and service providers to improve product quality, enhance risk management, and ensure patient safety in a highly regulated industry.
Specific Services
Quality System Gap Assessment
We evaluate your current QMS against ISO 13485 requirements to identify compliance gaps.
Read MoreDocumentation & SOP Development
We assist in creating required documents such as Quality Manuals, SOPs, Risk Management Files, and Technical Documentation.
Read MoreTraining & Awareness Programs
We train your staff on QMS, regulatory frameworks (like MDR/IVDR), and audit readiness.
Read MoreKey Benefits of ISO 13485 Certification
ISO 13485 enhances credibility in the medical device market by ensuring product safety, regulatory alignment, and effective quality management.
- Global Market Access
- Product Safety & Risk Reduction
- Enhanced Process Control
- Regulatory & Legal Compliance
- Customer Trust & Satisfaction
- Competitive Advantage
What is ISO 13485:2016 and who is it for?
ISO 13485 is a QMS standard tailored for medical device manufacturers, suppliers, and service providers, ensuring product safety, reliability, and regulatory compliance.
Is ISO 13485 mandatory for medical device companies?
While not legally mandatory in all countries, many regulators and clients require ISO 13485 certification for market approval and partnerships.
How does ISO 13485 relate to ISO 9001?
ISO 13485 is based on ISO 9001 but includes additional requirements focused on medical device safety, regulatory compliance, and risk management.