ISO 13485 Prerequisites Top Medical Device Quality Management Standard: FAQ

A medical device can be as simple as a bedpan or as complex as an individually designed sensor that remotely monitors the functionality of organs in breathing individuals. All medical devices, however, have one thing in common: they all strive to meet the highest level of internationally recognized quality standards when they are created by … Continue reading ISO 13485 Prerequisites Top Medical Device Quality Management Standard: FAQ

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Understanding ISO 13485 for Compliance and Quality

Many Global Regulatory bodies are including ISO 13485 into their requirements making the product suitable to the organization to help in aligning with the regulatory requirements with other elements of the standard. Greater emphasis on risk-based approaches The ISO 13485 standard does not have a high-level Annex SL structure. However, it requires risk-based approaches for … Continue reading Understanding ISO 13485 for Compliance and Quality

5 things about ISO 13485 Certification

5 things about ISO 13485 Certification

What is ISO 13485? ISO 13485 is the worldwide global standard for the foundation and upkeep of an archived quality management system for the medical device industry. Assuming a producer has carried out ISO 13485 Certification, it will have an establishment whereupon to affirm for provincial medical device guidelines like the EU Medical Device Directive … Continue reading 5 things about ISO 13485 Certification