I attended training in Advisera and got your contact as ISO 13485 consultant and have question regarding clause 4.1.3.
Here we can find, that for each quality management system process, the organization shall: determine criteria and methods needed to ensure that both the operation and control of these processes are effective.
And my question is:
if these criteria should be quantitative or qualitative?
and if we have Procedure for Document Control and Procedure for Control of Quality Records - these procedures have to include effectiveness criteria?Also, for instance we have described Change Management process and effectiveness criteria for this process are: Timely notification and implementation of changes; Data analysis results. Are these ok?
Different between "Supplier" and "Subcontractor"
one question regarding "10. Purchasing and Evaluation of Suppliers":
What is the different between "Supplier" and "Subcontractor"?
Hello,Thanks for your quick response.our commercial team produce a medical device as a startup business and we are in the MVP stage.I would like to ask you that is it necessary Iso13485 for it? So, if "yes" how can we should apply?With thanks
Conciliation between Iso 13485 and EU MDR
I want to understand all the requirements of EU MDR and their conciliation with ISO 13485 and FDA 21 CFR
Clean room criteria for ISO 13485
I have a 20 x 30 glass walled clean room sitting in a create for some time now and have decided to erect it so we can finally start working at an ISO 13485 situation. I would like to know for now only clean room criteria for iso 1 (class A) and based on that, I would like to know costs to retain you or cost to provide a cert jhow to go about getting an inspection etc
Question about notify body
I am putting an ISO 13485 QMS system. I have previously had 2 QMS systems in other companies accredited by notified bodies and thought that this is the only way to gain certification.
My present line Manager states other companies other than notified bodies can issue ISO 13485 instead of going down the notified body route, I am not sure that this is right. I cannot find a company that does this.
Am I right in thinking it has to be a notified body
What sections of ISO 13485 cover computer systems?
Would like to know what sections of ISO-13485 cover computer systems or is it another standard?
Auditing according to section 8.2.2
I've been asked to conduct a 13485 audit specific to complaint handling. Would I only need to audit according to section 8.2.2? Thank you!
IEC 62366-1 question
Hi Kristina – is this standard only applicable to medical devices with computer/software components?
If so, is there a different usability standard that pertains to non-computer related medical devices ?
Guidance for dealing with "old" devices
We have been marketing our devices in the EU since 2011 and have records and survaillance of these Class I devices since that time. These devices are cleansing devices for the eyelid, eyelashes and area around the eye but not for the eye itself. We also market a device called *** whose active ingredient is Tea Tree Oil in very low quantity or percent concentration. According to the guidance for Legacy devices MDCG 2021-25 issed October 2021, these devices are not considered "New' devices (devices to be submitted under the MDR and new to the EU market) nor or they considered " Legacy" devices (devices who were introduced to the market during the development of the MDR but before May 26, 2021. Our devices according to this guidance are considered "OLD" devices and defined as those devices that were placed on the market before 26 May 2021 in accordance with the AIMDD or the MDD or in accordance with the applicable rules before the directive had entered into force. . Is there a guidance for these "old" devices.