Custom Medical

Which human factors / usability engineering requirements apply to my combination product? This is a key question that needs to be addressed in every combination product project. But the answer is often less straightforward than it seems – and typically raises a number of detailed questions: Which requirements apply at all? Which ones apply in the context of FDA or ANDA? What distinguishes combination products from “classic” medical devices? What role does a threshold analysis play? When are additional human factors studies required? And which regulatory path is relevant for my product? That’s exactly what the on-demand webinar “𝗛𝘂𝗺𝗮𝗻 𝗙𝗮𝗰𝘁𝗼𝗿𝘀 𝗮𝗻𝗱 𝗨𝘀𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗘𝗻𝗴𝗶𝗻𝗲𝗲𝗿𝗶𝗻𝗴 𝗳𝗼𝗿 𝗖𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝘀”, hosted by Dr. Michaela Kauer-Franz, is about. In around 49 minutes, you’ll learn: 🔹 Which human factors requirements apply in the EU and US 🔹 How regulatory pathways (including ANDA) influence your approach 🔹 How threshold analysis determines the required level of effort Interested? ⬇️ Register for free and watch anytime

FDA or MDR, HF validation or summative — poor planning delays approvals. And yet, that’s exactly where too many teams find themselves: 📉 Tight deadlines 📉 Missing documents 📉 No clear timeline for the usability validation Free Webinar: Perfect Timeline for Summative Evaluations & Human Factors Validation Testings Here’s what you’ll learn: ✅ How to build a realistic timeline ✅ Common pitfalls for validation studies and how to avoid them ✅ Key differences in timeline between FDA and MDR 📅 Date: on-demand ⬇️ Register now for free

𝐔𝐩𝐝𝐚𝐭𝐞𝐝 𝐅𝐃𝐀 𝐠𝐮𝐢𝐝𝐚𝐧𝐜𝐞! Is your product a 𝐰𝐞𝐥𝐥𝐧𝐞𝐬𝐬 𝐩𝐫𝐨𝐝𝐮𝐜𝐭 𝐨𝐫 𝐚 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞? Unclear answers create real risk - or unnecessary regulatory effort. And that’s exactly where many teams get stuck: 📉 Evolving features and claims can push a wellness product into medical device regulatory scope 📉 A product originally developed as a medical device may now fall under general wellness 📉 Both scenarios often lead to uncertainty, rework, and late decisions Free On-Demand Webinar: 𝐖𝐞𝐥𝐥𝐧𝐞𝐬𝐬 𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞? 𝐇𝐞𝐫𝐞’𝐬 𝐰𝐡𝐚𝐭 𝐭𝐡𝐞 𝐧𝐞𝐰 𝐅𝐃𝐀 𝐠𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐬𝐚𝐲𝐬 Here’s what you’ll learn: ✅ How the FDA interprets general wellness products today ✅ Which claims, UX elements, and product features trigger regulatory scope ✅ How to avoid accidental medical claims during ongoing development ✅ Real-world examples of modern wellness and medical devices 📅 𝐃𝐚𝐭𝐞: on-demand - watch anytime ⬇️ 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐧𝐨𝐰 𝐟𝐨𝐫 𝐟𝐫𝐞𝐞

𝐀𝐫𝐞 𝐲𝐨𝐮𝐫 𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐯𝐞 𝐞𝐯𝐚𝐥𝐮𝐚𝐭𝐢𝐨𝐧𝐬 𝐚𝐜𝐭𝐮𝐚𝐥𝐥𝐲 𝐠𝐢𝐯𝐢𝐧𝐠 𝐲𝐨𝐮 𝐭𝐡𝐞 𝐢𝐧𝐬𝐢𝐠𝐡𝐭𝐬 𝐲𝐨𝐮 𝐧𝐞𝐞𝐝? A formative study can do much more than simply uncover usability issues. Done well, it helps teams make better design decisions, reduce uncertainty, and prepare more effectively for later development stages. But many teams still struggle with questions like: 📉 What should we test at this stage? 📉 Which study setup will give us the insights we actually need? 📉 How do we turn user feedback into meaningful design decisions? Free On-Demand Webinar: 𝐅𝐨𝐫𝐦𝐚𝐭𝐢𝐯𝐞 𝐄𝐯𝐚𝐥𝐮𝐚𝐭𝐢𝐨𝐧 𝐃𝐨𝐧𝐞 𝐑𝐢𝐠𝐡𝐭: 𝐖𝐡𝐞𝐧 𝐭𝐨 𝐓𝐞𝐬𝐭 𝐚𝐧𝐝 𝐖𝐡𝐚𝐭 𝐭𝐨 𝐋𝐞𝐚𝐫𝐧 Here’s what you’ll learn: ✅ Which formative approaches are useful throughout product development ✅ Which insights different types of formative studies can generate ✅ How to choose the right questions and study approach for your current development stage ✅ How formative evaluations can reduce risk and support a stronger summative evaluation 🎥 Approx. 23 minutes 🕒 Watch on demand ⬇️ 𝐆𝐞𝐭 𝐟𝐫𝐞𝐞 𝐚𝐜𝐜𝐞𝐬𝐬 𝐧𝐨𝐰

Can Agile really work in Medical Device software development? Many teams would like to become more flexible and respond faster to changing requirements, technical updates, or user feedback. But once IEC 62304, traceability, documentation, approvals, and risk management enter the picture, uncertainty often starts: How can Agile development remain compliant? How do you avoid losing Design Control? And how do teams prevent Regulatory Debt from quietly building up in the background? That’s exactly what the on-demand webinar “𝗠𝗼𝘃𝗲 𝗦𝗮𝗳𝗲𝗹𝘆 - 𝗔𝗴𝗶𝗹𝗶𝘁𝘆 𝗶𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁”, hosted by Daniel Ziegler, is about. In around 30 minutes, you’ll learn: 🔹 Why traditional development models often struggle with change 🔹 How Agile approaches can be aligned with IEC 62304 using AAMI TIR45 🔹 Which common pitfalls can put compliant development at risk 🔹 How to maintain flexibility without losing regulatory control Interested? ⬇️ Register for free and watch anytime

Möchten Sie Ihre berufliche Erfahrung als medizinisches Fachpersonal einbringen und dafür vergütet werden? Custom Medical sucht medizinisches Fachpersonal für bezahlte Usability-Studien zu Medizinprodukten, Software und digitalen Health-Produkten. Das erwartet Sie: 🔹 Vergütung von mindestens 90 € pro Stunde – häufig mehr* 🔹 Teilnahme remote oder vor Ort, je nach Studie 🔹 Sie entscheiden bei jeder Studie selbst, ob Sie teilnehmen möchten 🔹 Keine Verpflichtung und kein Beschäftigungsverhältnis 🔹 Wir kontaktieren Sie nur, wenn eine Studie zu Ihrem beruflichen Profil passt Interesse? ⬇️ Jetzt für bezahlte Usability-Studien registrieren *Die genaue Aufwandsentschädigung hängt von der jeweiligen Studie, Ihrer Expertise und den Teilnahmevoraussetzungen ab. Der von uns gezahlte Mindeststundensatz beträgt 90 €.