#DesignControl is an active hashtag on Bluesky. In the last 30 days, 7 people shared 16 posts with it — around 1 a day. The busiest day was Nov 2 with 3 posts.

Posts with #DesignControl

Thomas Brenner

@regafraid.bsky.social

1 day ago

Good news for Pace Surgical on the Tempo Plating System's 510(k) clearance; regulatory entry is only the beginning, though; the real test is whether surgeons find the plate simpler and more dependable in the OR. #MedicalDeviceQMS #DesignControl #FDACompliance

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Yuki S.

@regaffairsyuki.bsky.social

3 days ago

13485+14971+820, one DHF? Yoyogi approves. 🌿 youtube.com/watch?v=vxNG9… #DesignControl #MedicalDeviceQMS #ISO14971

www.youtube.com

Design History File, Reimagined in qmsWrapper

qmsWrapper connects your Design History File into one live, traceable system. Use cases, requirements, risks, and tests stay linked by default — with AI supp...

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Paige K.

@auditorpaige.bsky.social

7 days ago

Design-change reviews shouldn't mean manually hunting through requirements, risk controls, tests and documents, especially with notified-body capacity still stuck in first gear. youtube.com/watch?v=0fAIT… #RegulatoryAffairs #DesignControl #ChangeControl

www.youtube.com

Automating Change Impact Analysis for QMSR and ISO 13485 | Wrapper-Mapper Demo

How do you perform change impact analysis for QMSR and ISO 13485 without manually reviewing dozens of documents?In this demo, we show how Wrapper-Mapper auto...

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Thomas Brenner

@regafraid.bsky.social

7 days ago

TDM Co.'s Park's Pectus System earning FDA 510(k) clearance is good news. The distinction worth preserving: substantial equivalence, not demonstrated clinical superiority. #FDACompliance #ISO13485 #DesignControl

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Sarah O'Brien

@qmssarah78.bsky.social

7 days ago

Endox Test Strips securing FDA 510(k) clearance is good news. I'd still want plain-English instructions and sensible packaging, understanding the result shouldn't feel like another exam. #DesignControl #QualityManagement #FDACompliance

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Sarah O'Brien

@qmssarah78.bsky.social

15 days ago

Prodisc C family clears FDA. My spine approves. #FDACompliance #DesignControl #RegulatoryAffairs

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Daniela K.

@samqadani.bsky.social

17 days ago

Pelvic incidence rods: finally, a sensible name. #MedicalDeviceQMS #TechnicalFile #DesignControl

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The Nonconformance Report

@qmsnews.bsky.social

17 days ago

An auditor asks what safety grade your software is: A, B or C. ISO 13485 has no field for that. IEC 62304 does, and grade C means every anomaly gets documented, evaluated and closed as a record you can hand over. #IEC62304 #ISO13485 #DesignControl #Traceability #MedicalDeviceQMS #qmsWrapper

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Paige K.

@auditorpaige.bsky.social

18 days ago

Class III PMA. The DHF is the real story. #MedTech #DesignControl #TechnicalFile

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The Nonconformance Report

@qmsnews.bsky.social

23 days ago

Linear change workflows find the forgotten linked records at the CCO review, three days before release. Event-driven workflows flag them at intake. #MedicalDeviceQMS #ChangeControl #ISO13485 #DesignControl #qmsWrapper qmswrapper.com/qms-change…

qmswrapper.com

QMS Change Impact Analysis: Automated with qmsWrapper 10.2

QMS change impact analysis powered by AI helps medical device teams manage change, traceability, and Technical File updates.

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Daniela K.

@samqadani.bsky.social

23 days ago

if, complaints, and design controls are already linked in your qms, exporting them to a BI tool just to count open issues feels backwards. Walkthrough youtube.com/watch?v=76pQv… #DesignControl #MedTech #CAPA

www.youtube.com

Reporting in qmsWrapper

Reporting in qmsWrapperhttps://www.qmswrapper.com/use-cases/reporting-in-qmswrapper___qmsWrapperQuality Management System Software that helps all companies w...

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Paige K.

@auditorpaige.bsky.social

24 days ago

Three-in-one molecular panel cleared. Sensible. Cepheid's rapid tests genuinely useful in respiratory season. #FDACompliance #RegulatoryAffairs #DesignControl

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