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Checklist ISO 14971:2007 to ISO 14971:2019 Template (ISO 14971, Medical Device)

Checklist ISO 14971:2007 to ISO 14971:2019

29,00 €

This checklist can be used to update relevant processes, procedures, templates and risk management plans and records from ISO 14971:2007/EN ISO 14971:2012 to ISO 14971:2019.

SKU PT-ISO14971CHK Categories , Tags , , ,

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Note: Risk Management templates are included in the blended course.

Description

Why is it useful

This checklist can be used to update relevant processes, procedures, templates and risk management plans and records from ISO 14971:2007/EN ISO 14971:2012 to ISO 14971:2019. It references the “old” clauses and the relevant clauses in 2019.

How to use it

  1. Go through the checklist to identify needed changes in your system and records.
  2. Review the standard for additional changes.

Need risk management training and a course certificate?

If you should want to learn more about using the template or risk management in general, it is covered in our Risk Management for Medical Devices and ISO 14971 online course and our blended course Risk Management for Medical Devices and ISO 14971:2019 – Practitioner Training. Our blended courses combine a self-paced online course followed by a live virtual classroom session. You can also save money by purchasing our Advanced Risk Management course bundle which includes 3 online courses at a reduced price.

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Would you like to learn more about risk management or design control?

Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course. These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.

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