13485cert

Archive for the ‘Forward to MDA’ Category


3 Tools for Qualifying Suppliers

In Forward to MDA, Process Validation, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality, Supplier Survey on January 2, 2013 at 2:59 am

This blog has been moved to the following location and the name has been changed: http://bit.ly/3SupplierTools.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

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How do you audit design controls using the process approach?

In Change Control, Design & Development, Design Inputs, Design Outputs, Design Validation, Design Verification, Forward to MDA, Internal Auditing, IOVV, ISO 13485, ISO 14971, Risk Management on June 23, 2012 at 4:44 am

A new connection I made on LinkedIn joined the RA Review Group, and they suggested that anything related to the topic of Design and Development would be of interest for a blog topic. Therefore, I thought I would share a secret with everyone reading my blog…

This blog has been moved to the following location and the name has been changed: http://bit.ly/AuditDesign.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

I have left the links to the videos I love.

Entertainment for this week is Diana Krall‘s recording of Bésame Mucho. I have also included another recording by Andrea Bocelli with English and Spanish subtitles for anyone that wondered what the words meant. The song loses a little of it’s appeal in translation, but English is not one of the Romance Languages.


The Supplier Audit Agenda

In Audit Schedule, Contract Manufacturers, Forward to MDA, ISO, ISO 13485, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality on April 21, 2012 at 12:24 pm

This blog has been moved to the following location and the title has been changed: http://bit.ly/SupplierAuditAgenda.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

Supplier Survey with a Twist

In Forward to MDA, Supplier Qualification, Supplier Quality, Supplier Survey on March 29, 2012 at 4:35 am

This blog has been moved to the following location: http://bit.ly/SupplierSurvey.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

Which Suppliers Should You Audit?

In Audit Schedule, Contract Manufacturers, Forward to MDA, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality on March 26, 2012 at 4:55 am

This blog has been moved to the following location, and the title has been changed: http://bit.ly/WhichSuppliers.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

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Why did you Qualify that Supplier?

In Forward to MDA, Supplier Qualification, Supplier Quality on March 20, 2012 at 3:13 am

This blog has been moved to the following location, and the title has been changed: http://bit.ly/WhythatSupplier.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

How do you qualify a supplier that doesn’t have a Quality Management System?

In Forward to MDA, ISO 13485, Procedures, Purchasing, Quality Management Systems, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality, Supplier Survey on March 9, 2012 at 12:11 pm

This blog has been moved to the following location, and the title has been changed: http://bit.ly/NoQMSupplier.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

Who Does Supplier Audits in Your Company?

In Forward to MDA, Purchasing, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality on March 2, 2012 at 6:26 am

This blog has been moved to the following location, and the title has been changed: http://bit.ly/Whodoesaudits.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.


Supplier Evaluation – Take 5

In Forward to MDA, International Standard, ISO, Medical Device, Purchasing, QA, QC, Quality, Quality Management Systems, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality on January 3, 2011 at 9:47 pm

This blog has been moved to the following location and the name has been changed: http://bit.ly/SupplierEval-take5.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

Supplier Evaluation – Less is More

In Forward to MDA, International Standard, ISO, Medical Device, Purchasing, QA, QC, Quality, Quality Management Systems, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality on January 2, 2011 at 8:26 pm

This blog has been moved to the following location: http://bit.ly/Less-is-more.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

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