ISO 13485 & EU MDR - Expert Advice Community

Where requirement comes from to monitor and or record temperature and humidity during calibrations?

What I am attempting to figure out is where the requirement comes from to monitor and or record temperature and humidity during calibrations? Any information on this topic would be appreciated. 

Design master file

Is it required by 13485, MDR that the design master file (or similar naming) has to have control numbers, revision, and signoff, or is a date and sign off on the document sufficient. I will be thankfull for any help.

Medical Device File

I do have queries pertaining to implementation of ISO13485:2016.  

In particular on top of my list is about the Medical Device File or MDF.  Read through some articles, forums, blogs but I think I better seek advice from experts like you on this topic. 

Although the ISO standard explicitly stated major areas for compliance as per clause 4.2.3, sub-clauses (a) through (f). I am keen to know what exactly are the documented information that fall into these categories. 

I greatly appreciate receiving feedback from you on this subject.  Looking forward to receiving your reply. 

Change controls

I was wondering if you can help me with this question. This is regarding change controls specifically for changes to the quality system procedures such as SOPs and Work Instructions. How would these changes be initiated, reviewed and approved? I noticed there was not a change control form for this and I thought there would have been one in the Procedure for Document and Record Control.

How to implement Computer System Validation (chapter 7.5.6) without excessive effort and costs?

How to implement Computer System Validation (chapter 7.5.6) without excessive effort and costs in a small company?

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?)