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...