Scarlet

A well-executed literature search and review is crucial for your SaMD regulatory submission. There are a number of common mistakes to avoid, including: - A non-comprehensive database search - A non-comprehensive internet search - Poorly structured search terms - Insufficient detail for reproducibility - A failure to search citations of returned literature - Weak justification for decisions - A non-recent search In her second blog post on literature search and review, Kimberly Peven breaks down these common mistakes and how to avoid them. https://scr.lt/uguns8me

The EU AI Act will have a significant impact on the medical device industry. All AI medical devices that require conformity assessment by a Notified Body under EU MDR will be classified as "high-risk devices" under the EU AI Act. The Act mandates a continuous risk management system, a QMS, and a technical documentation file, though it does allow the incorporation of an AI-specific QMS into an already existing MDR one, and provides a legal basis for a single, combined technical file. Read more about what it means for SaMD manufacturers in our latest blog post from Camille Petri. https://scr.lt/1ajt3gtd

There are seven clear steps to conducting a literature search and review for medical device regulatory submissions, says Scarlet Clinical Engineer Kimberly Peven. 1. Define your objectives and research questions 2. Identify data sources 3. Develop search terms 4. Screen and select studies 5. Critically appraise studies 6. Extract data 7. Synthesise findings and report results Read the full guide here https://scr.lt/i10dx2na

Making SaMD requirements testable is vital. To do this, focus on two things: 1. Make them measurable - Use quantitative language and state-based explanations - avoid vague terms, and focus on specifics such as time limits or error rates. 2. Ensure feasibility - Frame requirements positively and realistically - statements like "zero downtime" aren’t achievable, but "95% uptime" is. Just as crafting proper requirements sets the framework for success, making them testable ensures your product can be developed and assessed in the right way. To read more, check out our latest Scarlet blog, by Matthieu Grillere at this link https://scr.lt/t3st4ble

Great to be featured in MedTech Leading Voice ahead of the Regulatory Affairs Professionals Society (RAPS)'s RAPS Convergence in Long Beach, CA. Thanks to Sean Smith for a great pre-game interview with our cofounder James Dewar. We're excited to be appearing on today's panel: "Notified Body Forum: State of Play EU MDR and EU IVDR", during which James will be articulating Scarlet's take on the evolving regulatory landscape for SaMD and AIaMD.

Real-World Evidence is crucial to the assessment and development of AI medical devices. Clinical trials are the gold standard for clinical evaluation, but they can take years to yield results and often do not fully represent real-world practices and diverse patient populations. RWE is derived from the actual experiences of diverse patient populations across various healthcare settings, and so is hugely valuable for post-market surveillance, continuous improvement, and ensuring AIaMD is safe, effective, and fair. It can also protect against two critical issues: Dataset shift - when the properties of the input data change and become different from the training data. Model drift - when the relationship between the inputs and predicted outcomes evolves due to changes in clinical practices, treatment protocols, or patient behaviours. RWE allows manufacturers to continuously monitor an AI model's performance in the real world, detect drift, and update the model accordingly. For more read the very first blog post by our AI Medical Device and Regulatory Specialist Camille Petri. https://scr.lt/rwe

"Manufacturers should start early, think critically, and plan for the long term." Our Head of Devices Sandy Wright explains why you should define meaningful, measurable, and patient-relevant clinical benefits for your software medical device to enable regulatory approval and market success. Read his latest blog post on the topic here https://scr.lt/dfclbnf5

"Manufacturers should start early, think critically, and plan for the long term." Our Head of Devices Sandy Wright explains why you should define meaningful, measurable, and patient-relevant clinical benefits for your software medical device to enable regulatory approval and market success. Read his latest blog post on the topic here https://scr.lt/dfclbnf5

Crafting proper requirements is crucial for the success of your software medical device. To do that, aim for requirements that are: - Clear - Concise - Singular In the latest Scarlet blog post, Matthieu Grillere explains why these three qualities matter, and how to achieve them. Read more here https://scr.lt/jq80ayhk #SoftwareMedicalDevices #SoftwareRequirements #MedicalDevices #RegulatoryCompliance #SaMD #MDR #DigitalHealth

Understanding clinical data is crucial for certifying software medical devices. Manufacturers need to provide three types of it: - Technical performance data - Clinical association data - Clinical performance data We detail exactly what each of these means in the latest Scarlet blog post, written by Head of Devices Sandy Wright https://lnkd.in/ej3v6krv #MedicalDevices #ClinicalData #RegulatoryCompliance #SaMD #SoftwareMedicalDevices #MDR #DigitalHealth