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									Device Documentation - Medical Device Courses Forum				            </title>
            <link>https://medicaldevicecourses.com/forums/device-documentation/</link>
            <description>Medical Device Courses Discussion Board</description>
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							                    <item>
                        <title>Simulation 1: Faulty Quality System</title>
                        <link>https://medicaldevicecourses.com/forums/device-documentation/simulation-1-faulty-quality-system/</link>
                        <pubDate>Thu, 15 Feb 2018 11:58:59 +0000</pubDate>
                        <description><![CDATA[In the first simulation this week, we are requesting changes to documents in the Quality System hierarchy. The hierarchy laid out in this simulation is the Quality Manual on the top, followe...]]></description>
                        <content:encoded><![CDATA[In the first simulation this week, we are requesting changes to documents in the Quality System hierarchy. The hierarchy laid out in this simulation is the Quality Manual on the top, followed by Quality System Procedures (QSP), followed by Work Instructions (WI), followed by the Specification on the lowest level. Many of these documents reference documents at different levels of the hierarchy. For example, the WI may reference the Spec. I want to pose the question, when these documents are referenced in another document, such as the example given, is it necessary to include the revision of the document? What are you thoughts?

My thoughts are that it is not necessary, because then when one document is updated to a new revision, it can create a cascading effect where all the documents that reference the updated document need to be revised as well so that they are not referencing an outdated document.]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/device-documentation/">Device Documentation</category>                        <dc:creator>srg36</dc:creator>
                        <guid isPermaLink="true">https://medicaldevicecourses.com/forums/device-documentation/simulation-1-faulty-quality-system/</guid>
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				                    <item>
                        <title>How to write SOP ? Which SOPs are for cGMP ?</title>
                        <link>https://medicaldevicecourses.com/forums/device-documentation/how-to-write-sop-which-sops-are-for-cgmp/</link>
                        <pubDate>Tue, 13 Feb 2018 17:01:44 +0000</pubDate>
                        <description><![CDATA[Hi Everyone,
SOPs are very important documents to build  a strong quality system. Let us discuss How to write SOPs, what should be included to avoid FDA audit ? 

For example:
I think Proced...]]></description>
                        <content:encoded><![CDATA[Hi Everyone,
SOPs are very important documents to build  a strong quality system. Let us discuss How to write SOPs, what should be included to avoid FDA audit ? 

For example:
I think Procedures is the most important part in any SOP document.Before starting to write, decide the exact purpose of the procedure. Once you have decided the exact purpose of the procedure, make sure everything you write contributes to that purpose for the medical device you are developing.

Share what do you think!]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/device-documentation/">Device Documentation</category>                        <dc:creator>merzkrashed</dc:creator>
                        <guid isPermaLink="true">https://medicaldevicecourses.com/forums/device-documentation/how-to-write-sop-which-sops-are-for-cgmp/</guid>
                    </item>
				                    <item>
                        <title>Does your company use ECOs?</title>
                        <link>https://medicaldevicecourses.com/forums/device-documentation/does-your-company-use-ecos/</link>
                        <pubDate>Tue, 06 Feb 2018 22:27:33 +0000</pubDate>
                        <description><![CDATA[For those of you who work in industry, I am curious whether your company uses ECOs or another similar form of documentation to execute a change to a product. My company uses the CCF (Change ...]]></description>
                        <content:encoded><![CDATA[For those of you who work in industry, I am curious whether your company uses ECOs or another similar form of documentation to execute a change to a product. My company uses the CCF (Change Control Form) process, and personally, I have found it to be very cumbersome. In order to initiate a change, the change request first has to be reviewed by a change control board (CCB), which holds weekly meetings, and often there are multiple follow ups with the CCB to make sure they agree with the proposed change and sign off on it. Once the change request is approved a change notice is created with an implementation plan detailing the tasks that must be completed before the CCF can close. Any changes to this plan must be reviewed and re-approved by the CCB, which also requires filling out an addendum to the form. I understand that all of this is in place to ensure to control the changes being made, but I think the process could definitely be more streamlined. I'm interested to hear your experience with ECOs and/or your company's equivalent document.]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/device-documentation/">Device Documentation</category>                        <dc:creator>srg36</dc:creator>
                        <guid isPermaLink="true">https://medicaldevicecourses.com/forums/device-documentation/does-your-company-use-ecos/</guid>
                    </item>
				                    <item>
                        <title>FDA vs. ISO</title>
                        <link>https://medicaldevicecourses.com/forums/device-documentation/fda-vs-iso/</link>
                        <pubDate>Mon, 20 Feb 2017 21:58:20 +0000</pubDate>
                        <description><![CDATA[According to the lectures, 

Process Validation according to the FDA is defined as &quot;results of a process cannot be fully verified by subsequent inspection and test.&quot; 

And process validation...]]></description>
                        <content:encoded><![CDATA[According to the lectures, 

Process Validation according to the FDA is defined as "results of a process cannot be fully verified by subsequent inspection and test." 

And process validation according to ISO is defined as "processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement." 

As Dr. Simon mentioned that these leave a lot of room for interpretation resulting in audits requiring changing your protocols or processes etc. 

My question is what are some examples where a product was on the market for a very long time and all of a sudden you get an audit requiring you to take it off the market. What processes or chain of events will you have to go through to get your product or device back on the market while fixing the issue by FDA or ISO standards. What is easier to work with FDA or ISO audits?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/device-documentation/">Device Documentation</category>                        <dc:creator>tn58</dc:creator>
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				                    <item>
                        <title>Validate or Not</title>
                        <link>https://medicaldevicecourses.com/forums/device-documentation/validate-or-not/</link>
                        <pubDate>Mon, 20 Feb 2017 21:44:00 +0000</pubDate>
                        <description><![CDATA[As Dr. Simon mentioned in the lecture on validate or not to validate. As he pointed out, that the best approach is to validate to reduce any future complaints or issues that may cause your d...]]></description>
                        <content:encoded><![CDATA[As Dr. Simon mentioned in the lecture on validate or not to validate. As he pointed out, that the best approach is to validate to reduce any future complaints or issues that may cause your device or product to go off market through an MDR.

Suppose you start a medical device company with a partner, how would you manage to understand the validation processes of the products or devices your company plans to launch on the market? How will you manage your employees and make sure they understand what the company you started wants as far as validation processes goes? Please share your experiences.]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/device-documentation/">Device Documentation</category>                        <dc:creator>tn58</dc:creator>
                        <guid isPermaLink="true">https://medicaldevicecourses.com/forums/device-documentation/validate-or-not/</guid>
                    </item>
				                    <item>
                        <title>Quality Management System Documentation Hierarchy</title>
                        <link>https://medicaldevicecourses.com/forums/device-documentation/quality-management-system-documentation-hierarchy/</link>
                        <pubDate>Sat, 18 Feb 2017 09:57:21 +0000</pubDate>
                        <description><![CDATA[Hi everyone, 

As we have learned from this week&#039;s simulation, The company&#039;s quality management system documentation hierarchy was as follows : Quality Manual, Quality System Procedure, Work...]]></description>
                        <content:encoded><![CDATA[Hi everyone, 

As we have learned from this week's simulation, The company's quality management system documentation hierarchy was as follows : Quality Manual, Quality System Procedure, Work Instructions (a.k.a. SOP). I have worked in multiple organizations that have defined their Quality Management System in different ways. One of the small organizations I worked for defined their QMS as follows:
- Quality Manual
- Quality Procedures
-  Records

While other organizations that I worked for defined their QMS as follows:
- Quality Manual
- Quality Policy
- Quality System Procedures
- Work Instructions
- Quality Records

From your experience, what is the advantages and disadvantages of each QMS? which is the best setup for a QMS and why?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/device-documentation/">Device Documentation</category>                        <dc:creator>Fady Khalla</dc:creator>
                        <guid isPermaLink="true">https://medicaldevicecourses.com/forums/device-documentation/quality-management-system-documentation-hierarchy/</guid>
                    </item>
				                    <item>
                        <title>SOP: how much detail before too much detail?</title>
                        <link>https://medicaldevicecourses.com/forums/device-documentation/sop-how-much-detail-before-too-much-detail/</link>
                        <pubDate>Sun, 12 Feb 2017 16:12:39 +0000</pubDate>
                        <description><![CDATA[Hi All,

Currently I am updating a few SOPs, some of them are having a complete rewrites and the technology has drastically changed since its last revision. As a result, some of the SOP that...]]></description>
                        <content:encoded><![CDATA[Hi All,

Currently I am updating a few SOPs, some of them are having a complete rewrites and the technology has drastically changed since its last revision. As a result, some of the SOP that I am writing have a step by step image and explanation of the procedure. I know my manager tells me that an SOP should be written so detailed that we can get a random person who has no experience with this process/procedure, but can execute the SOP with ease and success. So my question is how detailed is an SOP suppose to be, before it becomes too detailed and causes confusion/complications. 

Chris]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/device-documentation/">Device Documentation</category>                        <dc:creator>Chris Vasquez</dc:creator>
                        <guid isPermaLink="true">https://medicaldevicecourses.com/forums/device-documentation/sop-how-much-detail-before-too-much-detail/</guid>
                    </item>
				                    <item>
                        <title>Standard Operating Procedures (SOP&#039;s)</title>
                        <link>https://medicaldevicecourses.com/forums/device-documentation/standard-operating-procedures-sops/</link>
                        <pubDate>Sun, 12 Feb 2017 14:59:31 +0000</pubDate>
                        <description><![CDATA[During this week’s lecture, Dr. Simon discussed about SOP&#039;s and how they are part of the integrated quality system. He also described how they are important/required to be part of any GMP pr...]]></description>
                        <content:encoded><![CDATA[During this week’s lecture, Dr. Simon discussed about SOP's and how they are part of the integrated quality system. He also described how they are important/required to be part of any GMP process. Do you think that SOP’s should be required during the research phase? Can you provide some examples for those working in the industry?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/device-documentation/">Device Documentation</category>                        <dc:creator>Luisa Gutierrez</dc:creator>
                        <guid isPermaLink="true">https://medicaldevicecourses.com/forums/device-documentation/standard-operating-procedures-sops/</guid>
                    </item>
				                    <item>
                        <title>DHF vs. DHR</title>
                        <link>https://medicaldevicecourses.com/forums/device-documentation/dhf-vs-dhr/</link>
                        <pubDate>Fri, 10 Feb 2017 12:20:11 +0000</pubDate>
                        <description><![CDATA[Hey guys,

After going through the notes and google, I wasn&#039;t really able to tell the difference between a Device history file and device history record. For anyone who has experience in the...]]></description>
                        <content:encoded><![CDATA[Hey guys,

After going through the notes and google, I wasn't really able to tell the difference between a Device history file and device history record. For anyone who has experience in the industry, when do you need to generate a DHF vs. DHR? Also, what are major differences in these documents for someone who has to work them in the industry on a daily basis?

Experience and examples that can clear the confusion would be appreciated.]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/device-documentation/">Device Documentation</category>                        <dc:creator>tn58</dc:creator>
                        <guid isPermaLink="true">https://medicaldevicecourses.com/forums/device-documentation/dhf-vs-dhr/</guid>
                    </item>
				                    <item>
                        <title>Discussion Topic: ECO&#039;s</title>
                        <link>https://medicaldevicecourses.com/forums/device-documentation/discussion-topic-ecos/</link>
                        <pubDate>Mon, 06 Feb 2017 12:19:27 +0000</pubDate>
                        <description><![CDATA[Hi Everyone, 

This week, Dr. Simon talked about ECO&#039;s (Engineering Change Orders) and how they are used to change something about the medical device after the design controls are finished. ...]]></description>
                        <content:encoded><![CDATA[Hi Everyone, 

This week, Dr. Simon talked about ECO's (Engineering Change Orders) and how they are used to change something about the medical device after the design controls are finished. This can be a result of a few things, whether it is an error or a change in a regulation by the FDA or something else. From my experience, I have needed to use an ECO when a supplier of a raw material was no longer in business and we needed to find a new supplier of that material. 

My question for you is: 
What are some examples of a time or times that you have needed an ECO? What did you do to correct it?]]></content:encoded>
						                            <category domain="https://medicaldevicecourses.com/forums/device-documentation/">Device Documentation</category>                        <dc:creator>mjf34</dc:creator>
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