Tag: "Product: ISO 13485 & MDR Integrated Documentation Toolkit" - Expert Advice Community

Question about SaaMD

Is your toolkit for MDR compliance optimized for software as a medical device?

New requirements for technical files

We are working through our documentation with the help of Advisera. I do have questions on the new requirements for technical files. Do you have any samples or templates available?

Software Requirements

Firstly, how would the pack apply to Software as a Medical Device (SaMD)? Looking at the preview there is a lot that seems unnecessary as it is focused on the development of a physical product?

Secondly, on the software front where would Software Requirements be specified (e.g SRS Doc) is this kept as an external doc and referenced? On a similar line, what about Software Testing (e.g. unit testing, user testing)? Would you again keep an external record and link to it in the “Record of Software Validation”?

Section about intended use

IN the toolkit we have purchased, I cant seam to find a section about intended use. Which document caters for that? What ive found so far is just technical file, but not to the extent I thought was required.

ISO 13485 documentation question

 if we are only a distributor but may have to register products in the future would be these be the files that we would need

Procedure for the Software Life Cycle

I have vigorously started to implement the QMS in our company. I see that you do not have a separate procedure for the Software Life Cycle… Don’t you guys have such a template?

IS IEC 62304 included in toolkit Advisera offers?

Hi there. I have a question regarding your template for ISO 13485 & MDR documentation. We are an artificial intelligence medical software company that have to CE certify our first product. I read that - as a SaMD company - you also need to conform IEC 62304. Is this included in the toolkit Advisera offers?

Validation Procedure

Does the pack include one and I just can't find it? Or is that something you provide separately or at all?

Sterilization procedure template

1. We have a procedure “Sterilization” covering below topics:
Elements of the validation process - Bioburden Method validation - Bioburden enumeration -Sterilization process validation –
Sterility testing - Validation by The Bacteriostasis/Fungistasis Test - Sterility testing - EO residue - Bacterial endotoxins (LAL) test –
Product Package Testing - Functional test - Validation records and approval - Impact on manufacturing and packing in routine –Process review – requalification – Concession.

However we have a separate procedure on Sterility monitoring, covering below topics:
Microbial environmental monitoring - Product bioburden monitoring - Sterility testing (confirmation) -Bacterial endotoxins (LAL) test
Product Package integrity testing

In the sample we see from your documentation we only find “Sterilization”. Are the monitoring topics included in the Sterilization procedure template?

2.

The documents show a very adequate relationship to the ISO13485 paragraph that is the basis for the requirement.
Although most of these requirements are (then again) based on Article, annexes of the EU MDR (2017/745)
For example: For 7.3.9 (ISO) is based (now in MDR) on Annex IX, 2.2 c and Article 10.
Are there any referrals in the document point to these specific MDR article/requirements (possible?)

Document Control Numbers (Doc Code)

Having purchased the ISO13485 toolkit, I have a couple of questions related to Document Control Numbers (Doc Code).
We have a mature system, but it is due for overhaul and simplification. But because of our mature system, for most of the documents in your system we have existing Document Control numbers, many with considerable revision history. My preference is to renumber the documents to the Doc Codes in your List of Documents. is it considered best practice to include the Doc Control Number in a Document Change but keep the revision number in sequence? For example: Doc 00 (Procedure for Document and Record Control) Rev 1 (if we were implementing your document as a new document) is fine. But we are replacing our document 423-01 Rev 4 with this document. So would we do a Document Change that includes the renumbering of this document to 00, but use Rev 5 to clarify that this is not a new document (even though a new Doc Control Number)? Or is there a better approach to this?