Software in Medical Devices, by MD101 Consulting

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Friday 19 January 2018

FDA Guidance on Medical Device Accessories updated

Here is a quick follow-up of the new version of the FDA Guidance titled Medical Device Accessories – Describing Accessories and Classification Pathways, published in December 2017. This comes a bit in parallel to the Section 3060 guidance described in the previous post on the 21st Century Cures Act.

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Friday 12 January 2018

Consequences of the 21st Century Cures Act - State of Play

Since the last blog post on US FDA guidance on software classification, things evolved quickly with the FDA. We know where they want to go with software as medical device, but not exactly how they will implement it.
Let's do a review of what has been done since the publication of the 21st Century Cures Act.

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Tuesday 16 May 2017

Cybersecurity in medical devices - Part 3 AAMI TIR57:2016

After a long pause, we continue this series about cybersecurity in medical devices with a discussion on AAMI TIR57:2016 Principles for medical device security — Risk management.

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Friday 10 February 2017

Final FDA Guidance on Postmarket Management of Cybersecurity in Medical Devices - Final version released

This article is a follow-up of the previous article on the Draft guidance on Postmarket Management of Cybersecurity in Medical Devices.

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Final FDA Guidance on Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types

This article is a follow-up of the article on the Draft guidance on Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.

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Friday 4 November 2016

Software as a Medical Device (SAMD): clinical evaluation

The FDA released a guidance on clinical evaluation of standalone software medical device (a.k.a SAMD) in October 2016. This guidance is the same text and has the same presentation as the International Medical Device Regulatory Forum (IMDRF) guidance on SAMD clinical evaluation published in August 2016.

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Friday 19 August 2016

Three new FDA guidances

The FDA released three new FDA guidances in July 2016:

  • Two draft guidances on Deciding When to Submit a 510(k) for a Change to an Existing Device,
  • The final guidance on General Wellness: Policy for Low Risk Devices.

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Wednesday 10 August 2016

MEDDEV 2.1/6 2016

A new version of the MEDDEV 2.1/6 was published in July 2016.

The first version of 2012 was a major breakthrough. The new version won't change you life. Almost nothing new, excepted a few definitions on software, input data, output data, a remarkable reference to IMDRF definitions, and a non-significant update of the first decision tree.

Add to that a few typos, and you have the new version of the MEDDEV:

  • "lossless compression" disappeared from the decision tree (was it intentional?) but is still present in the explanations of decision step 3,
  • Decision step 7 doesn't have any explanation.


MEDDEV for nothing ♫ and tips for free ♬.

Friday 5 February 2016

New FDA draft guidance on interoperable medical devices

The draft guidance about Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices was published late January 2016.

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Friday 29 January 2016

FDA draft guidance on Postmarket Management of Cybersecurity in Medical Devices

The FDA released one week ago a new draft guidance on Postmarket Management of Cybersecurity in Medical Devices.
This guidance is the sister of the guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices released in 2014. Both guidances address cybersecurity at different steps of software lifecycle: the 2014 guidance is about cybersecurity during design and development, the 2016 draft guidance is about cybersecurity during post-market surveillance.

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Friday 20 March 2015

When the FDA releases guidances in burst mode

If you watch from time to time the new guidances released by the FDA, you probably noticed that two guidances about software were released in january and february 2015.

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Friday 12 December 2014

NBOG’s Best Practice Guide 2014-3: all you wanted to know about reporting software design changes

When should a manufacturer report devices changes or QMS changes to notified bodies, according to the 93/42/CE directive?
There hasn't been clear criteria, until the Notified Bodies Operating Group (NBOG) published the Best Practice Guide 2014-3 : Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System.

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Friday 21 November 2014

Analysis of the FDA Cybersecurity Guidance

At last! The FDA has published last October a guidance about cybersecurity that matters!
Not that the guidance previously published about Off-the-shelf software cybersecurity wasn’t worth reading it (Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software), but its scope was more than reduced.

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Friday 3 October 2014

Content of DHF, DMR and DHR for medical device software - Part 1 DHF

After a temporary absence, I'm back on the waves with a new series of articles to talk about the files required by the 21 CFR 820 regulations:

  • DHF: Design History File,
  • DMR: Device Master Record,
  • DHR: Device History Record.

Let's begin with the DHF.

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Friday 11 April 2014

Validation of compiler and IDE - Why, when and how to? - Part 3

Coming back to the discussion about validating compilers and IDE, here are a few more comments I have on this topic.

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Friday 14 February 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 6 Conclusion

To conclude this series about clearance of mobile medical apps, here are a few tips to newcomers in the world in medical devices.

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Friday 17 January 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 4 Usability

In the last article, we saw the concerns about the reliability of wireless connections and how to handle them.
Today, we are going to have a look at something quite important for mobile platforms: usability and humans factors engineering (HFE).

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Friday 3 January 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 3 Wireless

In the last article, we explained why agile methods are so popular for mobile app software development. Today, we are going to review a major characteristic of mobile platforms: wireless connection.

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Friday 15 November 2013

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 1 regulations

Today I begin a new series of articles about developing (or more broadly designing) a smartphone App that is a medical device.

The very first question is:

Is your App a medical device and does it need to be CE Marked or FDA cleared ?

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Wednesday 25 September 2013

FDA issues final Mobile Medical Apps Guidance

After two years of gestation, FDA issues final Guidance on Mobile Medical Apps!

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