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

Dot Compliance

ISO 13485 and ISO 14971 are two key standards that guide the safety and quality of medical devices. ISO 14971, on the other hand, outlines the risk management process for identifying, evaluating, and controlling risks associated with medical devices. Risk evaluation: Evaluating the effectiveness of risk control measures.

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Financial Experience: Empowering Patients to Improve Affordability

HIT Consultant

Consumer-Driven Technology to Benefit Patients and the Healthcare Ecosystem Focusing on patient experience, engagement, and empowerment not only benefits the consumer but the entire healthcare ecosystem. Similarly, improving patient satisfaction can help pharmacies build loyalty and boost the bottom line.

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How ISO 13485 Boosts Medical Device Quality

Dot Compliance

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).