Questions
Practical answers to recurring medical device compliance questions from founders, RA/QA teams and operators in the field.
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 a US-based test dataset mandatory for FDA clearance of dental AI software?
At our company, we are developing dental AI software and are preparing for FDA clearance in the US. We understand that having data from US sources is beneficial, but is it...
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...
Does software that analyzes EHR blood test results meet FDA CDS criterion 1?
Our company has a device that analyzes blood test results, biological sex, and age, with all input information coming from the electronic health record (EHR). According to the...
Are there FDA requirements for non-device clinical decision support software?
According to the new FDA guidance on clinical decision support software, our software is classified as a non-device. What are the requirements for bringing such software to the...
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...
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...
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...
Why can some US-marketed health software claim disease risk without FDA medical device approval?
I have seen a company marketing its software product in the US, making statements about disease risks (for example, providing cardiovascular or cancer risk scores) directly to...
Are there equivalent classifications to FDA Class I and II viewers under EU MDR?
According to the FDA, there are two classifications for medical image viewers: Class I for non-diagnostic viewers (intended only for review) and Class II for diagnostic viewers....
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...
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...
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 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 can the usability of the MDR and related standards be improved for startups?
One user described difficulties in applying the Medical Device Regulation (MDR) and related standards, especially as a startup. The user finds the regulations and standards...
Is EUDAMED registration mandatory for economic operators in Germany?
I understand from MDCG 2022-12 and Article 28 that EUDAMED registration is voluntary unless a member state requires otherwise. In Germany, it appears that registration in...