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Nederland Correctieblad norm NEN-EN-ISO 13485/C11 (en) Medical devices — Quality management system— — Requirements for regulatory purposes July 2007 ICS 03.120.10; 11.040.01 be eV Pr or Normcommissie

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Who needs nen-en-iso 13485c11 en:

1. Medical device manufacturers: Companies involved in the design, development, production, or distribution of medical devices need nen-en-iso 13485c11 en to ensure compliance with international quality management standards specifically tailored for the medical device industry.
2. Regulatory authorities: Government bodies and agencies responsible for overseeing medical devices, such as the Food and Drug Administration (FDA) in the United States, may request or require medical device manufacturers to adhere to nen-en-iso 13485c11 en as part of their regulatory compliance process.
3. Suppliers and subcontractors: Businesses that supply components, materials, or services to medical device manufacturers may be required to conform to nen-en-iso 13485c11 en to demonstrate their commitment to quality and safety in their operations.
4. Certifying bodies: Organizations responsible for certifying medical device manufacturers and ensuring their compliance with quality management systems standards may use nen-en-iso 13485c11 en as a benchmark for assessing conformance.

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What is nen-en-iso 13485c11 en?

NEN-EN-ISO 13485 is an international standard that specifies requirements for a quality management system specifically for the medical devices industry.

Who is required to file nen-en-iso 13485c11 en?

Manufacturers, suppliers, and distributors of medical devices are required to comply with the NEN-EN-ISO 13485 standard.

How to fill out nen-en-iso 13485c11 en?

To fill out NEN-EN-ISO 13485, companies need to implement and document quality management processes that meet the requirements of the standard.

What is the purpose of nen-en-iso 13485c11 en?

The purpose of NEN-EN-ISO 13485 is to ensure that medical devices meet regulatory requirements and are of high quality and safe for use.

What information must be reported on nen-en-iso 13485c11 en?

Information related to quality management processes, risk management, regulatory compliance, and product documentation must be reported on NEN-EN-ISO 13485.

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