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The Other Consultants

Adam Isaacs Rae

My unique take on Quality and Regulatory matters in the Medical Device industry

Platform
Substack
PricingOnly free issuesPublishesWeekly
Issues20SubscribersRead theotherconsultants.substack.com

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Latest Issues

Recent posts by this newsletter. Browse the email archive.

Make Audits Work for You

The rush to complete the audit schedule is an all too familiar occurrence.

2 months ago
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0

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:

2 months ago
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Choosing to use a standard or not belongs to the manufacturer - MDCG 2021-5 Rev 1

Are standards mandatory? The age old question. Below, I will attempt to outline some of the key documents and salient points that manufacturers can use.

3 months ago
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Documents of External Origin: Do I have to revalidate?

There have been a number of standards harmonised recently which have undergone revision. Monir El Azzouzi & I spoke of these the most recently I was on Easy Medical Device podcast discussing Sterilisation. Here is the link for reference - h...

4 months ago
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Authors

The writers behind this newsletter.

  • Adam Isaacs Rae

    Quality Management Consultant

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