Questions

Getting Started Technical Documentation Quality Management Clinical Evaluation QMS Software IVDR

Is it necessary to have technical documentation ready before certifying a QMS under MDR for a class IIa medical device?

Our company wants to certify its Quality Management System (QMS) as soon as all documentation is ready, but we do not yet have all the technical documentation for our medical device completed. Based o

Accepted answer

It's generally fine to proceed with certifying your QMS before the technical documentation for your device is complete, especially if you are aiming f

How do you validate and test your medical device IFU (Instructions For Use)?

Anonymous • 1 comment

1 day ago

Our team has previously added one or two tests about the IFU to our usability tests, but this approach felt awkward for testers and did not cover the entire IFU. We are seeking practical methods to va

Accepted answer

We've written a questionnaire with about 5-6 questions for users to answer after reviewing the IFU. The main focus is whether the instructions are cle

Is it necessary to have technical documentation ready before certifying the QMS under MDR for a class IIa device?

Anonymous • 2 comments

3 days ago

We are preparing to certify our Quality Management System (QMS) but do not yet have all of the technical documentation for our medical device completed. According to MDR 2017/745 (Annex IX, Chapter 1,

Accepted answer

Certification to ISO 13485 is independent from being a manufacturer under MDR Annex IX. Many certification bodies are not Notified Bodies for MDR, so

What happens after the Substantive Review and AI response in the traditional 510(k) process?

Anonymous • 1 comment

4 days ago

After the Substantive Review in the traditional 510(k) process, and after receiving and responding to the Additional Information (AI) request within the 180-day deadline, is the final 510(k) decision

Accepted answer

After you submit your response to the AI request, the FDA generally has 30 days to review it and make a decision. If they have additional questions, t

Is reduced time to triage via telemedicine a clinical benefit under MDR?

Anonymous • 2 comments

5 days ago

For telemedicine platforms that act as medical devices by generating data for review by a medical doctor (such as audio recordings of coughing or skin pictures), the goal is often to triage patients:

Accepted answer

I think you can definitely argue that reduced time to triage is a clinical benefit, since the MDR includes positive impact on patient management in it

How are feature flags managed under IEC 62304 compliance?

Anonymous • 1 comment

11 days ago

I am interested in how feature flags fit into the context of IEC 62304 for medical device software. Specifically, if a feature is deployed but hidden behind a feature flag, does enabling the flag cons

Accepted answer

Feature flags are generally considered a configuration, not a new release of the software. However, you must ensure that all possible configurations e

Are there general authentication requirements for patient mobile applications under MDR?

Anonymous • 2 comments

12 days ago

Are there any general guidelines or requirements under the Medical Device Regulation (MDR) for authentication in patient-facing mobile applications? I am specifically interested in requirements that w

Accepted answer

Overall, MDR does not specify detailed authentication requirements for patient mobile applications. The MDCG cybersecurity guidance mainly suggests us

Is ISO 13485 certification still valid if the medical device is discontinued?

Anonymous • 1 comment

13 days ago

What happens to an existing ISO 13485 certification if the medical device it was issued in combination with is discontinued? Is the ISO 13485 certification still valid for the company? Would the compa

Accepted answer

ISO 13485 certification is company-specific and not tied to a specific device. You can keep your ISO 13485 certification even if you don't have an act

When is a QMS required for medical device development?

Anonymous • 1 comment

14 days ago

At our company, we are preparing to implement a Quality Management System (QMS) and are unsure about the timing. Is a QMS required during the development phase, or only when preparing to put a medical

Accepted answer

Ideally, you would have your QMS in place before the development phase starts. In reality, most companies implement it during the development phase, s

Is ISO 13485 certification required before CE marking for medical device software in the EU and Switzerland?

Anonymous • 1 comment

15 days ago

Our company is planning to certify our software as a medical device in the EU and Switzerland. We have two questions: • Is it necessary to obtain ISO 13485 certification before pursuing CE marking? Wh

Accepted answer

One of the requirements for CE marking, depending on the classification of your device, is that you have a certified QMS in place. The MDR requires ma

Should we send all our developers to multi-day 8-hour "training sessions" for e.g. the ISO 13485?

Anonymous

16 days ago

Our CEO thinks that "quality is really important" and that "we need to show our investors and customers how much we value quality and safety", and has therefore sent everyone in the company to attend

Short answer: No, none of this makes sense. Your two most likely options are: • Convince the CEO that this is a huge mistake, save the company, and st

IEC 82304: How Is It Different From The IEC 62304?

Anonymous

updated 7 months ago

We're just getting started with our medical device documentation, and we initially thought that we need to comply with the IEC 62304 regarding our software documentation. Now, someone mentioned the IE

Accepted answer

Don't worry about it. Auditors won't like me for saying this, but the 82304 doesn't contain much additional content on top of the 62304. Just comply w

What's The Best QMS Software?

Anonymous

updated 9 months ago

We're looking for QMS software and don't know which one to choose. Which one is the best QMS software?y

Accepted answer

If you're a startup and don't know much about regulatory compliance yet, postpone that decision for now and learn a bit more about regulatory complian

Formative vs. Summative Usability Testing - What's The Difference?

Anonymous

updated 9 months ago

What's the difference between formative and summative usability testing?

Accepted answer

For summative usability testing, you need to do a user test (5 users or more in the EU, 15 in the US). For formative usability testing, you can "what

When Should We Start Documenting Our Medical Device And QMS?

Anonymous

updated 9 months ago

We are currently developing our software medical device and might be done in 6 months or so. We want to get started with documenting it right now! What can we do?

Accepted answer

If your software is not done yet, the most efficient approach in 95% of cases is to wait until your first version is done. For some reason, most peopl

Manual Tests vs. Automated Tests For Medical Device Software

Anonymous

updated 10 months ago

We're developing software as a medical device (SaMD), and we're unsure how to perform testing of our software. Should we set up an automated test pipeline or do manual testing?

Accepted answer

Do manual testing. I know it sucks, but it's more straightforward for many reasons. Long Answer Let me start off with this: I'm a software engineer m

Which Notified Body Should We Choose?

Anonymous

updated 10 months ago

Which Notified Body should we choose?

Accepted answer

DQS, BerlinCert, or maybe one of the lesser-known ones in Eastern Europe, in that order. Avoid BSI and Tüv Süd. Subjective opinion. Long Answer Discl

In-House Devices Under The MDR

Anonymous

updated 11 months ago

We are a University Hospital and developed a medical device software in-house that supports clinical decision making. Can we just use the software and do we need to involve a Notified Body?

Accepted answer

Set up some very basic quality management system procedures, do not provide your product to other hospitals and communicate well with your competent a

Flowcharts For ISO 13485: Should We Add Flowcharts To SOPs?

Anonymous

updated about 1 year ago

We're starting to document our processes for ISO 13485 compliance. For that, we're using the OpenRegulatory SOP templates. However, we're also wondering whether we should add flowcharts to those becau

Accepted answer

No. Long Answer Look, I get it, flowcharts in SOP documents look great and are actually more readable than the actual document. Like, if you're tryin

Can We Integrate Our eQMS With Jira, GitHub, Sharepoint, etc.?

Anonymous

updated about 1 year ago

We'd like to integrate our eQMS with our development tools like e.g. Jira, GitHub, Sharepoint and others. Does that make sense and how should we set it up?

Accepted answer

Don't do it, it doesn't make sense. Long Answer You're probably looking at eQMS software right now and are wondering which one of them integrates wel