4BetterDeviceshat einen Beitrag geschrieben.13. Juni 2023
📣 Today, let us debunk two widespread misconceptions about reports indicating no adverse events or zero occurrences of adverse events! ⬇...see more...⬇️
❌ MISCONCEPTION NO. 1: "A study reporting zero occurrences of an adverse event lacks valuable information for analysing that adverse event."
💡 This is false! It is crucial to distinguish between a study not mentioning an adverse event and a study stating that zero occurrences happened for a specific adverse event. The latter case provides va...
4BetterDeviceshat einen Beitrag geschrieben.10. Juni 2023
💡 Think that MDR requires data only for clinical validation? Think again… 🧠
The Medical Device Regulation (MDR) propels the medical device industry into Industry 4.0, championing data-driven decision-making processes at EVERY step of the product lifecycle:
- 𝗖𝗼𝗻𝗰𝗲𝗽𝘁𝗶𝗼𝗻: From the very beginning, data must the guiding light, revealing market trends, identifying similar devices, and highlighting novel technologies or new user needs.
- 𝗥𝗶𝘀𝗸 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁: Risks should be a...
