ISO 13485 & EU MDR - Expert Advice Community

Other ISOs used by the medical devices

Aside from ISO 13485 what are the other ISOs used by the medical devices?

Necessity of implementing ISO 14971 to obtain ISO 13485

Hi Kristina. Is it necessary to implement ISO 14971 to obtain ISO 13485:2016 if the company already has a risk management process (as per ICH Q9)

MDR QMS requirements

'm looking at your MDR QMS requirements table and I have a feeling it doesn't refer to all the correct MDR requirements i.e. Resource management (ISO 6) in MDR is states something about the control of suppliers and subcontractors... that's not resource management, same with A strategy for complying with regulations that's not 7.2

Training Validation for ISO 13485

I'm wondering how in depth I need to be in regards to training validation. Our training consists of reading the SOPs, and then signing off on their personal training records. My predecessor suggested creating an assessment quiz for each SOP, but it seems a little more labor intensive than the standard requires. I am thinking it might be more beneficial to create QMS assessment quizzes for certain processes (manufacturing dept, shipping dept, etc.) and then testing on a quarterly basis for comprehension and retention. ISO 13485 doesn't specifically say how this should be handled. I would appreciate any suggestions or feedback. Thank you!

Customers' Feedbacks and Complaints

Firstly, I hope you and your family are safe during this challenging time. 
I would like to thank you for your webinars. They are extremely helpful.

I am relatively new in this industry and I am struggling with a few quality related issues and I was hoping that maybe you could kindly have a minute to give me your expert opinion about the following:

1.) Would it be compliant that a medium size company (70  employees) to have separate procedures for Feedback and Complaint, Non-Conforming Product, Non-conformance and CAPA but the following logs: Feedback Log, Employee Suggestion Log (for employee feedback data gathering), CAPA log and just one log for both Complaints and Non-conformances.

2.) If there were 2 logs, one for complaints and one for non-conformances and a complaint is received that is investigated and considered a non-conformance, shall that complaint appear in both complaint log and non-conformance log? 
    Similarly, if a hypothetically a complaint is received and it is incident related, would it be registered in all logs applicable (complaint log, then incident log, then non-conformance log if it is due to a non-conformance, then in CAPA log when corrective action is required?) or can some of them be skipped (such as recording the incident straight into incident log rather than complaint log and in CAPA log to carry out relevant action plans?)

3) Is it  considered as being a complaint an instance when a customer is dissatisfied because his expectations are not met, but for meeting their expectations the regulatory requirements shall be broken?

I believe registering every issue that is detected in all the logs relevant is so confusing and time consuming.

Controlling Website Content

I recall that the website is considered a controlled document. Is it necessary to control the entire site, or just certain pages? I'm not exactly sure what QMS processes would apply, and if this needs its own SOP (or if it can be tacked on to another). Any advice would be greatly appreciated. Thank you!

Preparing the documentation

I have limited experience in ISO 13485 and I am trying to get the documentation ready for certification. I don't know where to go. I am doing most of the documents by myself and I am overwhelmed. Is there something that can help me figure out what documents align to what clause IE New product Inspections? What procedures and records I need to create and how to figure out what I am missing.

Training Validation

I'm attempting to devise a way to validate training, and am wondering if I need to do something for each SOP, or if I can simply create different versions of quizzes for a group of SOPs, and test on a quarterly or monthly basis. Any ideas would certainly help. Thank you!

Defining and documenting authorities

I need to define and document authorities in regards to yes/no and accept/reject scenarios. My plan is to create an organizational chart, and also to update all job descriptions to include their immediate supervisor. Is that adequate, or do I need to create a flowchart for each process, showing who has authority at each stage? 

Need for meeting requirements per FDA 21 CFR

Our Company will NOT be making medical devices. Company will be making components for the medical industry (Lighting Lenses, Handles, Covers) - Will we need to meet requirements per FDA 21 CFR?