ISO 13485 & EU MDR - Expert Advice Community

Internal auditor selection

We come across this clause in the Internal Audit procedure: 

[Job title] selects auditors in such a way as to ensure objectivity and impartiality, i.e. to avoid conflict of interest, because auditors are not allowed to audit their own work.

Given that our company is quite small, all employees are doing work relating to the ISO and therefore, an internal auditor may encounter something in the audit relating to their own work. Furthermore, the candidates that are able to assess all sides of the procedures (including the R&D technical side) are limited.

Does this mean that we have to hire an external auditor?

MDR classification

Best MDR classification of a non-invasive, low power (8mW pulsed at 10% duty cycle) near infrared sensor applied to skin (hand web) in a transitory fashion for use over extended periods of time?

Drug-device combination product development and manufacturing

My main question is what is the regulation or what level of ISO 13485 should be compliance for Drug-device combination product development and manufacturing, ie the pen-injector or auto-injector for insulin or other drug? 

Risk Management Question

We've been filling the risk management table on the 06th document but we have a question: ¿which processes should we include? Because we have many processes such as R&D, operations, production, QA, sales, delivery etc. but we wonder which ones should we include?

How long and how much for emdr 2a certification of software ai as medical device?

How long and how much for emdr 2a certification of software ai as medical device?

Validation of equipment

Hi, I was wondering if it is a requirement according to ISO 13485:2016 to use validated equipment during manufacturing and QC of IVDs

Distributors role in UK MDR changes

Hello

Would anyone have any upto date information documents on the role of distributors in UK MDD/ MDR.  With the changes of the MHRA now extending the deadline also, some of my customers and sub distributors are asking me questions that I don't have answers to, becasue as far as I was aware I can't see any changes that imapct distributors.

thanks 

Questions on Training Procedure and Procedure for Infrastructure and Work Environment

1. The reason of my mail is to ask you on which document of the toolkit can I find the one that describes the trainings product?

2. On the Procedure for Infrastructure and Work Enviroment document, on section 3.5 (Monitoring and measuring environmental conditios) I wonder if this section is necessary environmental conditions nor a cleanroom to do the device, the device is not invasive and it's mostly a software with sensors to check basic vital signs using IoT. Thank you very much for your help and I'll be
waiting for your answers.

Human resources appendixes question

This week we're working on the Human Resources documents and a few questions came up:

1. On the company there are a few courses from Udemy and Coursera that some employees have taken and others that are currently taking them, ¿are these courses considered as training programs so I can put them on the 4.1 and 4.3 Appendix?

2. Are training records (4.2 appendix) fully necesary? It's just that we currently don't implement trainings to monitor performance and we don't have trainings to fill the document, also, I understand this appendix refers to trainings that are needed due to bad performance, ¿am I right? Let me know if it refers to something else. 

Thank you very much and I'll be waiting for your answer.

Difference in UK and USA ISO 13485

I need to know if there is a difference in UK and USA ISO 13485?