Software in Medical Devices, a blog by MD101 Consulting

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Saturday 6 May 2017

MDR and IVDR published

Hello, The Medical Device Regulation and In-Vitro Device Regulation have been published the 5th May 2017!
See the Official Journal of the EU.

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This article is a follow-up of the previous article on the Draft guidance on Postmarket Management of Cybersecurity in Medical Devices.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This article is a follow-up of the article on the Draft guidance on Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.

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Monday 24 October 2016

Cybersecurity in medical devices - Part 1 Regulations

We begin today a series of posts on cybersecurity in medical devices. Cybersecurity was not a subject before the advent of computerized medical devices. Now that every manufacturer wants its connected medical device, cybersecurity matters!
Let's start with the regulations.

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Friday 2 September 2016

EU Medical Device Regulation - Changes for software

We've seen in the previous article the revolution in the regulatory classification brought by the new rule 10a for standalone software.
Let's see now the other changes. These changes are relevant for all software: standalone, embedded, device or accessory.
They're not as big as the new rule 10a, but they will deserve a significant amount of man-hours and documentation.

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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 22 July 2016

Is my software in class I, IIa, IIb or III - 2016 Revolution

The final version of the negotiated text of the new Medical Device Regulation (MDR) was published by the European Commission in June 2016. It is a big upheaval for all medical device manufacturers. Contrary to what the draft version of September 2015 contained, software is invited to the party.

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Wednesday 17 February 2016

Breaking news: standalone software is not an active medical device!

Warning: obsolete content. Please read: Is my software in class I, IIa, IIb or III.
Last update on 2016/07/31.

The British Standard Institute published in February 2016 a white paper titled How to prepare for and implement the upcoming MDR – Dos and don’ts. Register on BSI website to download the paper.
This white paper gives top-notch recommendations on the way to compliance with the future EU Medical Device Regulation (MDR), based on the draft version. But their interpretation of MDR classification rules on standalone software are somewhat surprising.

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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 28 August 2015

Validation of software used in production and QMS - Part 3 Validation Protocol and Reports

We continue this series on validation of software used in production and QMS with the Validation Protocol and Reports.

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Friday 24 July 2015

Validation of software used in production and QMS - Part 2 Validation Master Plan

We continue this series on validation of software used in production and QMS with the Validation Master Plan (VMP).
Better than endless explanations, I added a Validation Master Plan template to my templates repository page.

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Friday 15 May 2015

IMDRF document: Software as a Medical Device (SaMD): Application of Quality Management System

The International Medical Device Regulators Forum opened a consultation on a draft document about the application of Quality Management System for Software as a Medical Device (SaMD).
The consultation was opened in march and will be closed the 1st of June.

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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 31 October 2014

Content of DHF, DMR and DHR for medical device software - Part 3 DHR

We continue this series about DHF, DMR and DHR, with the Device History Record.

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Friday 17 October 2014

Content of DHF, DMR and DHR for medical device software - Part 2 DMR

We continue this series about DHF, DMR and DHR, with the Device Master Record.

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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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