Compliance, Medical Device Industry and Patient Satisfaction

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Compliance

Medical Device Industry

Patient Satisfaction

ISO 13485 vs. ISO 14971: Understanding Key Medical Device Standards

Dot Compliance

MARCH 26, 2025

In medical device manufacturing, companies must follow specific standards to ensure compliance. ISO 13485 and ISO 14971 are two key standards that guide the safety and quality of medical devices. Both standards are crucial, but they address different aspects of compliance.

Medical Device Industry

Medical Device Industry Regulatory Compliance Compliance Patient Satisfaction

How ISO 13485 Boosts Medical Device Quality

Dot Compliance

SEPTEMBER 13, 2024

The medical device industry balances innovation with patient safety. At the center of ensuring the reliability and effectiveness of these devices is ISO 13485, a globally recognized standard for quality management systems (QMS). This standard centers on patient safety, product quality, and regulatory compliance.

Medical Device Industry

Medical Device Industry Regulatory Compliance Compliance Patient Satisfaction

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Health Care Compliance Brief

ISO 13485 vs. ISO 14971: Understanding Key Medical Device Standards

How ISO 13485 Boosts Medical Device Quality

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