Profile

Hello, Are there any regulatory requirements pertaining to the use of 2D (QR Code) versus 3D barcodes on package labels for medical devices? Are they interchangeable, is one required in some markets but not others? Any guidance is greatly appreciated. Thank you!   ------------------------------ ...

Hello, We have a class II SaMD product that is marketed in the US. We often encounter issues when selling to US hospitals pertaining to lengthy cybersecurity and privacy questionnaires. The questionnaires are long and often different site to site. Does anyone have advice for which certifications or ...

Hello, We would like to provide an electronic IFU for a product but need to understand the requirements for Canada and the US. Apart from general labeling requirements for medical devices as defined by Health Canada and the FDA, and those specified in IEC 606061, are there any other requirements that ...

Hi, We have adopted a Threat and Risk Assessment approach per UL 2900-1 to assess security threats pre-market. Threat scenarios are assessed for each asset in scope to identify design controls, policy based risk mitigations and risks requiring ongoing remediation activities. We do not incorporate ...

Hello, I'm looking to connect with someone who has recently submitted a 510(k) for a class II SaMD. Specifically, I would like to know what security testing was submitted or requested. I am familiar with the list provided in the FDA Cybersecurity Guidance and other guidance documents from working ...