Technical Documentation
How to ensure user manual readability and usability during testing?
What are effective methods for ensuring that user manuals or Instructions for Use (IFUs) are readable and usable during testing? Are there recommended tools or formulas for...
UDI and EUDAMED Requirements for Legacy MDD Devices as of May 2023
Do legacy MDD devices need a UDI and/or to be registered in EUDAMED since May 2023, or has this requirement been postponed? There seems to be confusion regarding UDI labeling...
FDA requirements for SBOM submission: summary, machine-readable formats, and PDF attachments
Our company recently submitted a 510(k) and received questions from the FDA about our Software Bill of Materials (SBOM). Specifically, the FDA is asking for a "summary" of the...
FDA 'General Use' Classification for Surgical Instruments Intended for Specific Procedures
I am working on a device that appears to fall under FDA product code GDI (Dissector) as defined in 21 CFR 878.4800, "Manual surgical instrument for general use." However, this...
Should IT administrators be included as user roles in MDR technical documentation for SaMD?
During our recent MDR technical documentation review, the notified body requested that we include service personnel (administrators) as user roles in our product description....
How to convert GTIN-13 to GTIN-14 for EUDAMED UDI-DI submission?
EUDAMED appears to expect a GTIN-14 for UDI-DI, but most products have a GTIN-13 as default. Is it valid to add a leading zero to a GTIN-13 to create a GTIN-14 for EUDAMED?...
How to handle incremental software changes during MDR certification?
We are preparing our device for MDR certification but are struggling with the problem of incremental changes: • We submitted our Technical Documentation (TD) for version 2.14 in...
How to comply with EU 207/2012 electronic IFU requirements for medical device apps?
How should manufacturers of standalone software medical devices (apps) distributed via app stores comply with the requirements of EU regulation 207/2012 regarding electronic...
What name should appear on an IEC 60601 conformity certificate for hardware supplied by a third party?
Our medical device consists of both hardware and software. The hardware is supplied by a third-party supplier, who is also organizing the conformity testing to IEC 60601. The...
Experience navigating significant change notifications under MDR/IVDR for SaMD
Are you working in regulatory affairs or quality assurance at a software as a medical device (SaMD) company with a device certified under MDR or IVDR? I am interested in your...
How to handle MDR (EU) 2021/2226 Article 5.3 and 5.4 requirements for eIFU?
I am looking for guidance on how to handle the requirements from Article 5.3 and 5.4 of (EU) 2021/2226 regarding electronic instructions for use (eIFU): • Article 5(3): What...
How to select the appropriate EMDN code for stand-alone medical device software?
I need to register a stand-alone medical device software in EUDAMED and am uncertain which EMDN code to use. V92 - MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES seems...
How to find UMDNS and GMDN codes for SaMD?
What is the best way to find the UMDNS and GMDN codes for a software as a medical device (SaMD)? I've tried searching the freely available lists online using various keywords,...
Difference between Annex IX and Annex XI for MDR Class IIa Technical File Review
Hello, In terms of MDR Class IIa Technical File review (certification), what is the difference between Annex IX and Annex XI?
What are the requirements for 'Authentisierung von GKV-Versicherten' for DiGAs in Germany from January 1st?
I am seeking clarification on the mandatory requirement for 'Authentisierung von GKV-Versicherten' (authentication of statutory health insurance holders) that applies to DiGAs...
Using Own Device as Equivalent Device During MDD to MDR Transition
Is it permitted to use a company's own device as an equivalent device during the transition from MDD to MDR? For example, if a device was Class I under MDD and will transition...
Is CE marking required for internally used EEG analysis software provided as a service to hospitals?
We are a startup providing EEG analysis services to psychiatric hospitals using software developed for our own internal use. We are ISO 13485 certified and initially planned to...
Is it necessary to include device classification and intended use in every section of DHF and TD documentation?
Is it required to always include sections with device classification, device description, intended use, contraindications, and indications at the beginning of every document in...
Can a software feature be labeled as RUO or performance evaluation only within a medical device software?
Is it possible for one feature within a software product to be labeled as Research Use Only (RUO) or for performance evaluation only, while the rest of the software is a medical...
Are commercial VR headsets and computers considered medical device accessories under MDR when sold as a system with SaMD?
At our company, we develop software for cognitive assessments that requires a virtual reality (VR) headset (such as an HP headset) and a computer to operate. The software is...
Are amendments to the Declaration of Conformity needed for non-significant UI changes shown in screenshots?
For legacy MDD devices, if a change is made to the user interface (UI) that is purely cosmetic (e.g., color of a separation line) and not related to presentation of medical...
What is my company's role under MDR when incorporating a CE-marked software medical device from another manufacturer into our non-medical app?
I am planning to incorporate a CE-marked software solution (manufactured by another company) into our app, which itself is not a medical device. The software will be made...
How to handle identification and validity of electronic controlled documents under ISO 13485?
Our company manages ISO 13485 documentation electronically, using GitHub for drafting and SharePoint for final, signed PDF versions. ISO 13485 requires prevention of unintended...
Difference between MDR Annex IX and Annex XI for Class IIa Technical File Review
In the context of MDR Class IIa technical file review (certification), what is the difference between Annex IX and Annex XI? Specifically, are there significant advantages to...
Labeling requirements for multiple models in FDA 510(k) submissions for software
We are preparing to submit FDA 510(k) clearance for multiple software models (e.g., for different diagnostic modalities) within the same software product. Are there specific...
How will the new EU AI Regulation affect conformity assessment for medical devices?
The European Commission recently published a proposal for regulating AI systems. This regulation is not specific to medical devices but applies horizontally to all AI...
Are there specific formatting requirements for GS1 field 8012?
Does anyone know if there are specific formatting requirements for GS1 field 8012, especially for software versioning? At our company, we considered using code 240, but our...
Tips for documenting SaMD compliance with the EU AI Act (Articles 4 & 5)
Our company is preparing for the February 2, 2025, EU AI Act deadline. We are working on: • A statement confirming our SaMD avoids prohibited AI practices (Article 5). • A...
How do you validate and test your medical device IFU (Instructions For Use)?
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...
Is it necessary to have technical documentation ready before certifying the QMS under MDR for a class IIa device?
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...
How are feature flags managed under IEC 62304 compliance?
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...
IEC 82304: How Is It Different From The IEC 62304?
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,...
Formative vs. Summative Usability Testing - What's The Difference?
What's the difference between formative and summative usability testing?
Manual Tests vs. Automated Tests For Medical Device Software
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?
Can We Do Agile Development For Our Medical Device Software?
We want to do agile development. Can we do agile development for our medical device software?
We're In A Rush. Can We Automate Our Technical Documentation Completely?
We're In A Rush. Can We Automate Our Technical Documentation Completely?
What's the Minimum Number of Users for a Usability Test?
We’re planning our usability testing, i.e. our IEC 62366 - compliant Summative Usability Evaluation. Is there any sort of minimum number of users we need to include?
What is a MDR UDI? Unraveling the Importance of Unique Device Identification
What is a UDI in the context of the MDR and FDA?
What is IFA?
What is IFA? And what does it have to do with UDIs?
What is a GS1? Shedding light on the UDI provider
What is GS1? And how do we get GS1 UDIs?