The Other Consultants: MedTech Quality & Regulatory Insights
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I've built a tool to help schedule internal audits
It's free and I'd love you to give me some feedback
Jun 23
•
Adam Isaacs Rae
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The Other Consultants: MedTech Quality & Regulatory Insights
I've built a tool to help schedule internal audits
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April 2025
Selamat Datang - Get your medical device on the Malaysian market 🇲🇾
As on Easy Medical Device
Apr 24
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Adam Isaacs Rae
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The Other Consultants: MedTech Quality & Regulatory Insights
Selamat Datang - Get your medical device on the Malaysian market 🇲🇾
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Team NB Guidance on Best Practice Guidance (BPG) for Technical Documentation v3
+ a newsletter update
Apr 14
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Adam Isaacs Rae
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The Other Consultants: MedTech Quality & Regulatory Insights
Team NB Guidance on Best Practice Guidance (BPG) for Technical Documentation v3
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March 2025
Has MDSAP met its objectives?
The Medical Device Single Audit Program (MDSAP) had it’s inaugural meeting in Singapore in 2012.
Mar 26
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Adam Isaacs Rae
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Has MDSAP met its objectives?
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UK Medical Devices - What's the latest?
February's releases
Mar 4
•
Adam Isaacs Rae
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The Other Consultants: MedTech Quality & Regulatory Insights
UK Medical Devices - What's the latest?
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January 2025
Objectivity and Impartiality of the Audit Process
Is your QMS effective at determining whether it's effective, suitable and adequate?
Jan 2
•
Adam Isaacs Rae
2
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The Other Consultants: MedTech Quality & Regulatory Insights
Objectivity and Impartiality of the Audit Process
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2
December 2024
Sneak Peak: Economic Operators Case Studies
Thank you for your support, so you have it first.
Dec 2, 2024
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Adam Isaacs Rae
1
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Sneak Peak: Economic Operators Case Studies
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November 2024
Come and have a chat :)
A private space for us to converse and connect
Nov 20, 2024
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Adam Isaacs Rae
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The Other Consultants: MedTech Quality & Regulatory Insights
Come and have a chat :)
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October 2024
Internal Auditor Competency: How much is enough?
Never enough...
Oct 31, 2024
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Adam Isaacs Rae
2
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The Other Consultants: MedTech Quality & Regulatory Insights
Internal Auditor Competency: How much is enough?
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August 2024
Make Audits Work for You
The rush to complete the audit schedule is an all too familiar occurrence.
Aug 28, 2024
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Adam Isaacs Rae
2
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The Other Consultants: MedTech Quality & Regulatory Insights
Make Audits Work for You
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QARA essentials (same as LinkedIn but with extras)
Really short post of (hopefully) useful information here on some extremely useful items that I and a few others I know use really frequently:
Aug 26, 2024
•
Adam Isaacs Rae
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The Other Consultants: MedTech Quality & Regulatory Insights
QARA essentials (same as LinkedIn but with extras)
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Choosing to use a standard or not belongs to the manufacturer - MDCG 2021-5 Rev 1
Are standards mandatory?
Aug 7, 2024
•
Adam Isaacs Rae
2
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The Other Consultants: MedTech Quality & Regulatory Insights
Choosing to use a standard or not belongs to the manufacturer - MDCG 2021-5 Rev 1
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