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Medical Devices Manufacturing | Regulatory and Quality Management Insights

Regulatory and Quality Management Insights

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Medical Devices Manufacturing | Regulatory and Quality Management Insights | medqms.wordpress.com Reviews

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Regulatory and Quality Management Insights

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1

January | 2012 | Medical Devices Manufacturing

https://medqms.wordpress.com/2012/01

Regulatory and Quality Management Insights. ISO 13485 Exclusions and Non-applicability. 3 January, 2012. Interpretation of the omission allowances of ISO 13485:2003. By C Pereira, QA/RA Specialist at RegPass Quality Management. The purpose of this post is to provide clarity regarding allowable exclusion and non-applicability of certain requirements of international quality management standard ISO 13485:2003. ISO 13485:2003 Clause 1.2. Some regulatory jurisdictions permit manufacturers to release for sale.

2

Schrödinger’s Medical Device: Is not. Is too! | Medical Devices Manufacturing

https://medqms.wordpress.com/2010/11/22/schrodingers-medical-devices

Regulatory and Quality Management Insights. Schrödinger’s Medical Device: Is not. Is too! The other night I was watching an episode of. The Big Bang Theory. And saw the most hilarious use of the. In the TV show, one character is told that she could curb her anxiety about an upcoming first date by adopting the. I wish I had seen this episode a few weeks earlier because I could have introduced. 8221; and was in turn asked, “What difference does it make? When we are in our medical devices arena and have our...

3

August | 2010 | Medical Devices Manufacturing

https://medqms.wordpress.com/2010/08

Regulatory and Quality Management Insights. Accredited Vs. Non-Accredited QMS Certification. 5 August, 2010. In our field of medical devices manufacturing, we will at some point be faced with selecting a new supplier for a material, component or service. Normally we would initiate a selection process whereby we identify a set of potential suppliers and attempt to determine each candidate’s ability to effectively deliver that product or service to required specifications. For example, my grandmother can p...

4

Was THAT a complaint? | Medical Devices Manufacturing

https://medqms.wordpress.com/2010/08/05/was-that-a-complaint

Regulatory and Quality Management Insights. Was THAT a complaint? Hi Jane, I am just calling to let you know that I received my order this morning. I actually expected it to be delivered two days ago, but that’s okay because I actually need it for tomorrow morning so I suppose we can say it got here one day early eh? The receptionist was trained to record and report complaints to the quality manager but yet did not record or relay any part of this conversation to anyone. Should she have? In a culture of ...

5

ISO 13485 Exclusions and Non-applicability | Medical Devices Manufacturing

https://medqms.wordpress.com/2012/01/03/iso-13485-ex-na

Regulatory and Quality Management Insights. ISO 13485 Exclusions and Non-applicability. Interpretation of the omission allowances of ISO 13485:2003. By C Pereira, QA/RA Specialist at RegPass Quality Management. The purpose of this post is to provide clarity regarding allowable exclusion and non-applicability of certain requirements of international quality management standard ISO 13485:2003. ISO 13485:2003 Clause 1.2. Some regulatory jurisdictions permit manufacturers to release for sale. Medical devices...

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Medical Devices Manufacturing | Regulatory and Quality Management Insights

Regulatory and Quality Management Insights. ISO 13485 Exclusions and Non-applicability. 3 January, 2012. Interpretation of the omission allowances of ISO 13485:2003. By C Pereira, QA/RA Specialist at RegPass Quality Management. The purpose of this post is to provide clarity regarding allowable exclusion and non-applicability of certain requirements of international quality management standard ISO 13485:2003. ISO 13485:2003 Clause 1.2. Some regulatory jurisdictions permit manufacturers to release for sale.

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