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ISO 13485 - Medical Devices

ISO 13485 is an International Organization for Standardization (ISO) standard for a comprehensive quality management system for the design and manufacture of medical devices.

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ISO 13485 is a standard for a comprehensive quality management system for the design and manufacture of medical devices. This standard emphasizes risk management, maintaining effective processes, and meeting regulatory and customer requirements.

Organizations do not need to be actively manufacturing medical devices or their components to seek certification to this standard. ISO 13485 certification can also be the first step in achieving compliance with European regulatory requirements.

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Freer Pinpoint Blog

Regulatory Compliance and Quality Programs: Constraints and Opportunities of Integration

Brian Freer ISO Standards Compliance‚ management system‚ Program Management‚ Uncategorized

Find out more how Freer Consulting can help your business with regulatory compliance and quality programs. By examining the costs and benefits of implementing process-based integrated management systems, organizations may gain insight into the potential value of merging regulatory compliance with quality programs. As an example, the food processing industry is regulated by the Food […]

AISC Updates Steel Fabrication Standard

Brian Schefke Industrial Standards Certification‚ ISO Standards Compliance

https://www.freerconsulting.com/aisc-certification-consulting The American Institute for Steel Construction (AISC) has updated its steel fabrication standard, now titled Standard for Certification Programs 207-20, which supersedes the prior Certification Standard for Steel Fabrication and Erection, and Manufacturing of Metal Components 207-16. The new standard takes effect on June 1, 2021 and is available for download. A brief summary […]

New Edition of AWS D1.1/D1.1M Standard Released

Brian Schefke Industrial Standards Certification‚ ISO Standards Compliance

The American Welding Society (AWS) has released the 2020 revision of the D1.1/D1.1M Structural Welding Code for steel. You can find a summary of the changes on the American National Standards Institute website here and a YouTube video from the AWS describing the changes in more detail here. If you would like help becoming certified […]

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