[button size='medium' style='' text='Test Version' icon='fa-angle-double-right' icon_color='' link='https://pages.convertkit.com/0ffcb9c1d6/6c50ef737b' target='_blank' color='' hover_color='' border_color='' hover_border_color='' background_color='' hover_background_color='' font_style='' font_weight='' text_align='center' margin='0 25 0 0 ']

We invested over 1000 hours to develop and optimize this IVDR Gap-Assessment Tool incl ISO 13485:2016 references. The integrated reference table helps to find the IVDR impacts on your QMS immediately. Download our test version today to get a first impression of how it works, and how powerful this correlation table can be.

This tool is Excel-based because:

- No software installation required
- Your highly sensitive data are 100% under your control
- You do not have to trust any third parties

Benefits:

• Reference table to ISO 13485:2016
• Including a Gap-Report
• Including a Project-Plan
• Free corrigendum updates until May 2022
• Significant saving of working hours
• Unique keyword search function
• Complete table of content (Chapter, Annexes, incl. all articles)

What you get:

• Instruction for use
• Technical Support
• Customer feedback improved tool

Our Payment Partners:

The post IVDR Gap-Assessment Tool incl. ISO 13485:2016 first appeared on Regulatory Globe.

[button size='medium' style='' text='Test Version' icon='fa-angle-double-right' icon_color='' link='https://pages.convertkit.com/e015f06bdc/531595b7a0' target='_blank' color='' hover_color='' border_color='' hover_border_color='' background_color='' hover_background_color='' font_style='' font_weight='' text_align='center' margin='0 25 0 0 ']

Developed in cooperation with: 

QUNIQUE and Regulatory Globe invested over 1000 hours to develop and optimize this MDR Gap-Assessment Tool incl ISO 13485:2016 references. The integrated reference table helps to find the MDR impacts on your QMS immediately. Download our test version today to get a first impression of how it works, and how powerful this correlation table can be.

This tool is Excel-based because:

- No software installation required
- Your highly sensitive data are 100% under your control
- You do not have to trust any third parties

Benefits:

• Reference table to ISO 13485:2016
• Including a Gap-Report
• Including a Project-Plan
• Free corrigendum updates until May 2021
• Significant saving of working hours
• Unique keyword search function
• Complete table of content (Chapter, Annexes, incl. all articles)

What you get:

• Instruction for use
• Technical Support
• Customer feedback improved tool

Our Payment Partners:

The post MDR Gap-Assessment Tool incl. ISO 13485:2016 first appeared on Regulatory Globe.

Developed in cooperation with: 

Recommended by:  

This tool is Excel-based because:

- No software installation required
- Your highly sensitive data are 100% under your control
- You do not have to trust any third parties

Benefits:

• Simple overview / No paper chaos
• Easy to sort by specific county requirements
• The checklist supports well during the implementation
• Helpful overview during the next MDSAP audit

What you get:

• Instruction for use
• Technical Support
• Customer feedback improved tool

[button size='medium' style='' text='Test Version' icon='fa-angle-double-right' icon_color='' link='https://pages.convertkit.com/2e5f82a44d/dbe3d0e9c3' target='_blank' color='' hover_color='' border_color='' hover_border_color='' background_color='' hover_background_color='' font_style='' font_weight='' text_align='center' margin='0 25 0 0 ']

Our Payment Partners:

The post MDSAP vs. ISO 13485:2016 Checklist first appeared on Regulatory Globe.

[button size='medium' style='' text='Test Version' icon='fa-angle-double-right' icon_color='' link='https://pages.convertkit.com/74c4b9474e/96be463103' target='_blank' color='' hover_color='' border_color='' hover_border_color='' background_color='' hover_background_color='' font_style='' font_weight='' text_align='center' margin='0 25 0 0 ']

Our Payment Partners:

The post ISO 13485: 2016 Checklist first appeared on Regulatory Globe.