Documents required by MDSAP and FDA in ISO 13485 Documentation Toolkit

1. Do you have in your 13485 & MDR package documents required by MDSAP? If no, where I can get them.

In our ISO 13485 & MDR documentation toolkit, we have all the necessary documentation for the internal audit which is very similar to MDSAP Documents. These are the following documents:

• Procedure for Internal audit
• Internal audit checklist
• Internal audit program<
• Internal audit plan
• Internal audit report

On this link you can see the list of the documents that we have in our Documentation toolkit https://advisera.com/13485academy/iso-13485-internal-audit-toolkit/: 

The list of MDSAP audit procedures and forms you can find on the following link: https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/mdsap-audit-procedures-and-forms

More information on ISO 13485:2016 internal audit process you can find in the following articles:

• Five main steps in the ISO 13485:2016 internal audit https://advisera.com/13485academy/knowledgebase/five-main-steps-in-the-iso-134852016-internal-audit/
• How to create a checklist for an ISO 13485 internal audit for your QMS https://advisera.com/13485academy/knowledgebase/how-to-create-a-checklist-for-an-iso-13485-internal-audit-for-your-qms/

2. The same question about your 13485 & MDR package documents required by FDA?"

Medical device regulation is applicable to all medical devices that want to be placed on the EU market. Necessary Technical documentation is described in Annex 2 and Annex 3 of the MDR 2017/745.

Here are the links to that Annexes:

• EU MDR Annex 2 – Technical documentation - https://advisera.com/13485academy/mdr/technical-documentation/
• EU MDR Annex 3 – Technical documentation on post-market surveillance – https://advisera.com/13485academy/mdr/technical-documentation-on-post-market-surveillance/

We, in our ISO 13485 & MDR Documentation Toolkit have prepared the obligatory procedures and reports. Other test reports depend on the type of medical device and it was not possible to standardize it. Below you can see listed these documents:

• Procedure for clinical evaluation and related documents
• Procedure for post-market surveillance and related documents
• Technical documentation procedure and related documents

A 510(k) is the technical dossier required by the US Food and Drug Administration (FDA) to sell a medium-risk medical device or IVD in the United States. It is formally called a Pre-market Notification. A 510(k) contains detailed technical, safety, and performance information about a medical device. The documentation must demonstrate the device in question is "substantially equivalent" to a predicate device (i.e. a product already cleared for sale in the US). The FDA must review the 510(k) and "clear" your device before you can legally sell or distribute it in the United States.

Here is the link to the content of the 510(k):

• Content of a 510(k)  https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k
• Premarket Notification 510(k) https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k

Differences between MDR and FDA 510(k) are in some definitions, classes, and in the clinical investigation trials. Therefore, you can use our templates from our documentation toolkit. However, once again I repeat that this documentation is not all the required documents, and plans, reports, and results of different tests can not be standardized.