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- Indexed issues, last 90 days
- 11
- Latest publication
- Sep 30, 2026
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- Jul 22, 2026
Latest issues
Benchmark Drift: Why Acceptance Criteria Age (opens the original)
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Hey friend,One unchanged acceptance criterion can stall your renewal.That sounds unfair at first.Your device has not changed. Manufacturing is steady. The complaint rate is flat. The acceptance criteria sailed through review five years ago.Then the questions arrive.Picture the team opening that email. A PDF is attached. Someone reads the question twice. Around the table, the first reaction is confusion: how can a threshold that was accepted before suddenly become a problem now?That moment carrie
Deficiency Letters: How Reviewers Reason, How to Close a Round (opens the original)
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Hello dear,One contradiction in your file can open another deficiency round.The email lands with a PDF attached, and somewhere in your building a stomach drops. Perhaps you are the person who opens it. You scan the first page, see the list of points, and feel the deadline settle on your shoulders.I know that feeling.You may also know the loneliness behind it. Everyone wants to know what the letter means, how serious it is, and when it will be closed. Yet you may be the only person in the buildin
The Last Page a Reviewer Reads First (opens the original)
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One sentence at the end of your CER can put the whole file in doubt.That is why I want to talk about the last page that gets read first.The reviewer opens your conclusion early because they want to know where you are asking the evidence to take them. Then they return to it after reading the file, carrying every table, criterion, limitation, and inconsistency they found along the way.Only then does trust enter the room.A convincing conclusion feels like the final step of a path the reviewer has a
The Sentence Marketing Wrote That Your CER Cannot Defend (opens the original)
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Hello dear,One sentence your clinical team never wrote can stall the file they worked so hard to build.That sentence may be sitting on the website. It may be glowing on a congress-booth wall, repeated in a sales deck, or tucked into the IFU. Someone wrote it with pride. Then the reviewer asks a quiet, devastating question: where is the evidence?That question tends to land with a thud.The clinical team opens the CER. Marketing opens the website. A quality colleague searches old approvals. Suddenl
Article 61(10): When 'No Clinical Data' Still Means Clinical Work (opens the original)
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Hey dear,Four words can give a device team dangerous relief: no clinical data necessary.The mood in a team changes when it reaches that conclusion. Shoulders drop. The pressure seems to lift. For a moment, it feels as if one difficult part of the MDR has disappeared.I understand that feeling.And this is the part that still bothers me: the relief arrives too early.Article 61(10) covers devices for which clinical investigations or clinical data are not deemed necessary. That can sound like an exem
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