Dot Compliance

MARCH 26, 2025

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.

Medical Device Industry 59

Medical Device Industry Regulatory Compliance Compliance Patient Satisfaction 59

Dot Compliance

JANUARY 7, 2025

Enhance regulatory compliance: Comply with Good Laboratory Practices (GLP) and other relevant regulations. Scenario 3: Medical Device Manufacturer Improves Patient Safety Now well look at the medical device industry.

Medical Device Industry 59

Medical Device Industry Regulatory Compliance Compliance FDA 59

Dot Compliance

JANUARY 30, 2024

Introduction: In the fast-evolving landscape of the medical device industry, ensuring the highest quality standards is paramount. By streamlining workflow processes, medical device companies can allocate resources more efficiently, freeing up personnel to focus on strategic tasks rather than routine administrative functions.

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Medical Device Industry Compliance Regulatory Compliance 52

Dot Compliance

SEPTEMBER 27, 2024

Regulatory Focus ISO 13485 is specifically aligned with the regulatory requirements of the medical device industry. It mandates detailed procedures for traceability, enabling the tracking of devices from raw materials to the end-user.

Medical Device Industry 59

Medical Device Industry Compliance Regulatory Compliance 59

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). ISO 13485: Key Takeaways ISO 13485 provides a framework for medical device quality systems.

Medical Device Industry 52

Medical Device Industry Regulatory Compliance Compliance Patient Satisfaction 52

Dot Compliance

SEPTEMBER 2, 2024

Navigating the complexities of ISO 13485 can be overwhelming for medical device manufacturers. This international standard sets the benchmark for quality management systems (QMS) in the medical device industry, ensuring product safety and efficacy.

Regulatory Compliance 52

Regulatory Compliance Compliance Medical Device Industry 52

Dot Compliance

JUNE 16, 2022

Millions of dollars are lost by manufacturers every year due to regulatory non-compliance issues and related lawsuits. We continuously hear of infractions and warnings issued to companies for lack of regulatory compliance. The FDA 21 CFR Part 820 is the mandatory standard for medical devices distributed in the US.

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FDA Regulatory Compliance Compliance Governance 52