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ISO 13485:2016

ISO 13485:2016

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**ISO 13485:2016**

What is ISO 13485:2016?

ISO 13485:2016 is an internationally recognized standard that specifies requirements for a quality management system (QMS) specific to the medical device industry. Organizations use it to demonstrate their ability to consistently meet customer and regulatory requirements applicable to medical devices and related services. It covers all stages of a medical device's lifecycle, from design and development to production, installation, and servicing. Certification to ISO 13485 is often required for companies seeking to market their medical devices in various global markets.

Find 538 organizations using ISO 13485:2016 on Sumble →

What other technologies are related to ISO 13485:2016?

ISO 13485:2016 Complementary Technologies

ISO 14971:2019
ISO 14971:2019
ISO 14971:2019 is a standard for applying risk management to medical devices. It's strongly complementary to ISO 13485:2016, which focuses on quality management systems, as risk management is an integral part of ensuring product safety and effectiveness.
MDSAP
MDSAP
MDSAP (Medical Device Single Audit Program) is a program that allows medical device manufacturers to be audited once for compliance with the regulatory requirements of multiple countries. It complements ISO 13485 by streamlining the auditing process for global market access.
21 CFR 820
21 CFR 820
21 CFR 820 is the FDA's Quality System Regulation for medical devices, which outlines current good manufacturing practice (CGMP) requirements. It is complementary to ISO 13485:2016, as both aim to ensure quality and regulatory compliance in medical device manufacturing, but 21 CFR 820 is specific to the US market.
Number of organizations that mention technology
538
ISO 13485:2016
69
ISO 14971:2019
492
MDSAP
465
21 CFR 820
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Which job functions commonly mention ISO 13485:2016?

Public Policy
0.1% of all Public Policy jobs mention ISO 13485:2016
View 120 jobs on Sumble
Quality Engineer
0.1% of all Quality Engineer jobs mention ISO 13485:2016
View 223 jobs on Sumble
Quality Assurance
0.1% of all Quality Assurance jobs mention ISO 13485:2016
View 446 jobs on Sumble
Quality Analyst
21 Quality Analyst jobs mention ISO 13485:2016
View 21 jobs on Sumble
Operations
473 Operations jobs mention ISO 13485:2016
View 473 jobs on Sumble
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