Will it take more time than the age of the universe?
Thursday, 28 September 2023
Time it takes an evaluator to review your tech file in 2023
By Mitch on Thursday, 28 September 2023, 18:02 - Misc
Friday, 8 September 2023
AAMI SW96 2023 - The keystone of security risk management for medical devices
By Mitch on Friday, 8 September 2023, 14:30 - Standards
A new standard on security risk management for medical devices was published early 2023: AAMI SW96. Unlike AAMI TIR57 and TIR97, this is a standard, not a technical report.
Friday, 16 June 2023
Final FDA guidance on Content of Premarket Submissions for Device Software Functions
By Mitch on Friday, 16 June 2023, 13:54 - Regulations
The final version of the FDA guidance on Content of Premarket Submissions for Device Software Functions has been published.
Monday, 20 February 2023
Maintained software, Supported software, Required software, and SOUP
By Mitch on Monday, 20 February 2023, 13:56 - Standards
These three concepts come from IEC 62443 and were adopted in IEC 80001-5-1. SOUP isn't present in IEC 81001-5-1.
What are the differences between SOUP and Maintained software, Supported software, and Required software?
Monday, 9 January 2023
IEC 81001-5-1 was added to the list of recognized consensus standards
By Mitch on Monday, 9 January 2023, 15:31 - Regulations
The FDA added late December 2022 IEC 81001-5-1 to the list of recognized consensus standards.
That's it. After beating around the bush on this blog on whether UL 2900-x or IEC 81001-5-1 would be applicable to 510(k) submissions and other regulatory clearances, we now have the answer.
We can use IEC 81001-5-1 as:
- A Secure Product Development Framework according to the latest draft FDA guidance on cybersecurity,
- A method of answer to GSPR on cybersecurity of EU MDR and IVDR.
A good way to make thing (a bit) more simple.
Remark: UL 2900-x can still be applied in the US!
Friday, 6 January 2023
FDA Guidance on Clinical Decision Support Software
By Mitch on Friday, 6 January 2023, 13:24 - Regulations
The latest version of the FDA Guidance on Clinical Decision Support Software (CDSS) was published in September 2022. Here is a review of the document and a short comparison with the status of CDS with regard to the MDR.
Friday, 16 December 2022
Manual on Borderline Classification Version 2 - December 2022
By Mitch on Friday, 16 December 2022, 13:50 - Regulations
The Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022 has been published yesterday.
Monday, 5 December 2022
Letter to EPSCO for their meeting of the 9th December 2022
By Mitch on Monday, 5 December 2022, 11:47 - Misc
Hi EPSCO!
I hope you’re doing well!
We’re a bit concerned by your mindset, it looks like you don’t know where you have to go at your meeting of the 9th December.
Please find below some suggestions just for you.
Friday, 11 November 2022
Computer Software Assurance for Production and Quality System Software
By Mitch on Friday, 11 November 2022, 13:24 - Processes
That's a bit like a new album of your favorite group. You've been waiting it for years. At last, it's been released! Are you going to be be impressed or disappointed?
The draft FDA guidance on Computer Software Assurance [CSA] for Production and Quality System Software has been published in September 2022. At last!
Friday, 30 September 2022
NIS2 Directive: are you involved or concerned?
By Mitch on Friday, 30 September 2022, 14:01 - Regulations
That’s the story of the pig and the hen for breakfast: the pig is involved (ham) and the hen is concerned (eggs). With the NIS2 directive in preparation, a medical device manufacturer will be in either situation.
Friday, 2 September 2022
MDCG 2022-14: Red Queen Effect
By Mitch on Friday, 2 September 2022, 12:47 - Regulations
The MDCG published in August 2022 the MDCG 2022-14 position paper on Notified body capacity and availability of medical devices and IVDs.
Friday, 8 July 2022
IEC/TR 60601-4-5 kicked out of harmonized standards
By Mitch on Friday, 8 July 2022, 13:52 - Standards
The 6th June 2022, a draft request has been published to update the list of EU MDR/IVDR harmonized standards. This request brings changes to the list presented in the draft list of April 2021.
Monday, 27 June 2022
MDR: Les Shadoks and MHRA: The Gibis
By Mitch on Monday, 27 June 2022, 14:50 - Regulations
The UK Government response to consultation on the future regulation of medical devices in the United Kingdom has been published on Sunday 26th June 2022.
Tuesday, 14 June 2022
MDCG 2022-11 - Monty Python and the Holy Grail
By Mitch on Tuesday, 14 June 2022, 21:41 - Misc
Have you seen the MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements?
Friday, 10 June 2022
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission
By Mitch on Friday, 10 June 2022, 13:47 - Regulations
The FDA issued in April a new draft guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This guidance will supersede the guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices of 2014, when it is finalized. There’s no word about the draft guidance of 2018. We can suppose that one is obsolete.
Monday, 23 May 2022
The MDR is born bad
By Mitch on Monday, 23 May 2022, 13:08 - Regulations
The Medical Device Regulation (MDR) is born bad. The success of a project depends on its timing. It is clear that the MDR has been plagued by a series of setbacks that have hindered its implementation.
Friday, 13 May 2022
Software as a Medical Device Post-Market Surveillance
By Mitch on Friday, 13 May 2022, 13:55 - Regulations
Post-Market Surveillance (PMS) is one of the strengthened requirements of the Medical Device Regulation (MDR). Performing an effective PMS can be a time consuming task, shared by several departments of MD manufacturers. This is also true for SaMD.
Friday, 22 April 2022
New SaMD Classification scheme
By Mitch on Friday, 22 April 2022, 14:20 - Misc
A new unofficial SaMD classification scheme. Will it be adopted with the postponement of the MDR?
Friday, 15 April 2022
SaMD decommissioning, recall, removal and withdrawal
By Mitch on Friday, 15 April 2022, 14:26 - Regulations
We saw in the previous post how the lifetime of a SaMD can be defined. Let's continue with the operations that can affect this lifetime.
Friday, 25 February 2022
Medical Device lifetime and SaMD
By Mitch on Friday, 25 February 2022, 14:28 - Regulations
Medical device regulations require the manufacturers to define lifetime for their devices. In the case of SaMD, this requirement needs some interpretation.
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