ISO 13485 & EU MDR - Expert Advice Community

The best approach for QMS

Hi Team,

We are Relabeler/Repackager of our Product. We are looking at QMS for our company which is start up and getting the goods into USA.

We would like to know what is the best approach for the QMS.

ISO 13485:2016 laboratory equipment

1. In what way is the laboratory equipment involve in the ISO 13485 ?

2. If laboratory equipment is used within a project for a medical device then does this need to be included in the QMS ?

3. Is the ISO based on a medical device the company is trying to sell or is this for all instruments used for the development of devices?

Validation of software of machines and equipment related to production process

Need to validate the software of machines and equipment related to the production process and not to the product.

Which records need to be signed with a hand-written signature (or electronic equivalent)?

Which records need to be signed with a hand-written signature (or electronic equivalent)? Thanks!

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?)

Do manufacturing of medical face mask require clean room?

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?

Differences between ISO 13485:2003 and ISO 13485:2016

1. What are the exact differences between ISO 13485:2003, ISO 13485:2016?

2. What portions of FDA cGMPS, are being revised to comply with ISO 13485:2016?

15223-1 and 13485 certification question

Do i need to purchase iso 15223-1 in order to comply with a medical device app? Furthermore can the iso 13485 certification and the CE certification be done by the same organization?

Lot number coding

Our company recently purchased Advisera’s package of ISO 13485 templates for implementation in our company as we are starting producing class I medical devices (surgical gowns) to supply the Portuguese market as soon as possible.

I’m aware you provide a meeting to discuss doubts about the templates provided, but at the moment I’m in a hurry to solve an issue regarding the lot number coding and I didn’t find any information about that in the package purchased.

Is there any template to help us code the lot/batch number of a medical device or mandatory information that we should include in that code? We want to allocate that code automatically, but we don’t know what requirements to demand from the automatic batch number allocation.

Would you kindly help me with this matter?