Quality Management
Trend reporting is a PMS input or output?
Annex III of MDR: • The PMS plan shall address the collection and utilization of available information, in particular: information from trend reporting; • The post-market...
Is internally used diagnostic software considered a medical device under MDR?
Our company has developed three software components related to EEG and ECG biomarkers to support psychiatric treatment decisions: • A web interface for hospitals and clinics to...
Is it appropriate to exclude ISO 13485 section 7.6 for SaMD under IVDR?
Our product is a Software as a Medical Device (SaMD) that falls under the IVDR. It uses blood and genetic data as input to calculate disease risks for patients via machine...
Examples for SOP content for Infrastructure and Work Environment in ISO 13485 QMS for software
Our company is establishing a QMS according to ISO 13485, and I have been asked to identify procedures, assign them to the standard's clauses, and draft SOPs. My background is...
Is the FDA planning to drop Part 11 requirements for electronic records?
There was a discussion about whether the FDA is considering dropping Part 11 requirements for electronic records. The question was raised because the FDA's proposal mentions...
How to refine and standardise data quality control requirements for medical device algorithms?
Data quality control is important for medical device product quality, especially for data-based algorithms. What efforts are made to standardise data quality control...
How should change control be applied to complementary software in medical device projects?
How should change control be implemented for software that complements a medical device? Should the change evaluation apply only to the medical device software, or should it...
How to prepare for MDR QMS audits by Notified Bodies?
What are some effective strategies to prepare for MDR (Medical Device Regulation) QMS (Quality Management System) audits conducted by Notified Bodies? Are there specific...
How to ensure GDPR compliance for patient data logging in a digital health clinical trial?
We are preparing to launch our first clinical trial for a digital health app for diabetes. Our process is as follows: collect patient data via the app, store it locally, export...
Is a new QMS audit required for MDR certification if we already have MDD and ISO 13485 certification?
Our company has a device certified under the MDD with a certified QMS (quality management system). We are planning to transition to MDR certification. Do we need to undergo a...
Is ISO 13485 certification required before CE marking for software medical devices in the EU and Switzerland?
We want to certify our software as a medical device in the EU and Switzerland. I have two questions: • Is it necessary to first obtain ISO 13485 certification before applying...
Is the EU planning to clarify regulation of continuously learning AI in medical devices?
I am looking for literature or official documentation indicating that the EU is planning to provide more clarity regarding the regulation of continuously learning or dynamic AI...
Recommendations for EU Notified Bodies for CE and MDR applications outside Germany
Our company is developing a medical device software and is seeking recommendations for Notified Bodies in the EU, outside of Germany, where we can apply for CE marking and MDR...
Are EU MDR obligations triggered if an EU manufacturer sells via a distributor outside the EU?
Does the EU MDR place any obligations on an EU-based manufacturer if a product is sold outside the EU through a distributor? For example, if our company manufactures a device in...
How do you handle CAPA investigations and bug triage for SaMDs?
I am interested in how companies handle CAPA (Corrective and Preventive Action) investigations, especially for Software as a Medical Device (SaMD). In our startup, root causes...
How do companies handle MDR Annex III complaint investigation and market experience analysis?
According to MDR 2017/745, Annex III, paragraph 1(b), manufacturers must implement effective and appropriate methods and tools to investigate complaints and analyze...
How do you assess and qualify SOUP suppliers, and how do you determine their criticality?
Do you assess and qualify suppliers of SOUP (Software of Unknown Provenance)? For example, some SOUP items like cloud infrastructure can directly impact product safety and...
Best team setup for Class I (EU) medical device QMS and technical documentation?
We are a small team preparing to set up our Quality Management System (QMS) and Technical Documentation for a Class I medical device in the EU, which includes a hardware...
SaMD : Is the frontend part of the medicla device under EU MDR ?
In a CE-marked SaMD under EU MDR, only the backend of our software performs the medical function (clinical data processing, rule evaluation, alert generation). The frontend...
How to implement BSI TR-03161 and similar requirements in a QMS for DiGA?
I came across BSI TR-03161 regarding DiGA requirements. How should these requirements be implemented in an existing system? Should some be added as QMS procedures, and others as...
Is it Formwork useful if not yet made a spin-out?
Hi. We are a team at an institution working trying to develop a SaMD. We haven't spinned-out yet, if we achieve to do it somewhere in the following years. A colleague recently...
How should substantial and significant changes be reported to notified bodies under MDR?
I am seeking clarification on how to interpret and report substantial or significant changes for medical devices under the MDR, particularly for Class IIb and IIa devices....
How to handle risk analysis for regression vs classification models in AI medical devices?
When performing risk management for AI-based medical devices, how should the analysis differ between classification and regression models? For classification models, risks are...
How should changes to organizational details (e.g. CEO, company address) be tracked in a QMS under MDR?
During our recent MDR audit, we received a minor non-conformity because changes to our quality management system (QMS) are not tracked systematically. Product changes are...
Have there been safety issues or field safety notices with AI-based medical devices?
Is anyone aware of any documented safety issues or field safety notices (FSNs) that have been issued for AI-based medical devices? If so, are there specific databases or sources...
How much harder is it to document Class C software than Class B
We think our software may be classified as Class B or C depending on whether we include an attractive feature. How much harder is it to document Class C software? Are there...
EUDAMED and .xml Bulk Upload Files - How Do They Work?
Hi there! With EUDAMED looming 5 months out from now everyone is hard at work getting their data in order, ready for submission. However, one of the methods of data upload...
Documents mentioned in SOP Deployment
The template for SOP Deployment mentions a number of documents under "Relevant other documentation". This list includes: • Integration Evaluation Checklist (IECL) • Integration...
How should changes to a QMS unrelated to the product be tracked under MDR?
During a recent MDR audit, a minor non-conformity was issued because changes to our quality management system (QMS) that are not related to the product (such as changes in...
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...
Is ISO 13485 certification still valid if the medical device is discontinued?
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...
When is a QMS required for medical device development?
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...
Is ISO 13485 certification required before CE marking for medical device software in the EU and Switzerland?
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...
In-House Devices Under The MDR
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...
Flowcharts For ISO 13485: Should We Add Flowcharts To SOPs?
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...
Which Data Should We Collect In Our Post-Market Surveillance?
We are an established manufacturer of a class IIb medical device software. Our software is a mobile app intended to analyze a user’s heartbeat, detect abnormalities and inform a...
How To Analyze And Report "Trends" Under The MDR?
We are setting up the PMS plan and according to the MDR Article 88 we need to report trends. We also need to do that based on statistically significant increases. What do we...
What's the Difference Between a Document and a Record?
What the hell is the difference between a document and a record?
Software Validation Procedure for ISO 13485 compliance?
We’re currently using GitHub for our code repositories. Now we’ve heard that this sort of software needs to be “validated”. What does that mean? Do we have to write tests for...