---
title: Blog | Medical Device (2)
description: Medical Device | Stay updated on Life Science through expert insights, industry trends, latest news and more with PQE Group's blog. (2)
---

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# **Latest Insights**

[Medical Device ![](https://blog.pqegroup.com/hubfs/Continuous%20Manufacturing%20ICH_Site%20PQE-1.jpg)](https://blog.pqegroup.com/medical-device/new-trends-in-guidelines-for-continuous-process-manufacturing)

22 May 2023

## [New Trends in Guidelines for Continuous Process Manufacturing The importance of Continuous Manufacturing (CM) and its different approaches. The new guidelines and trends of continuous manufacturing explained.](https://blog.pqegroup.com/medical-device/new-trends-in-guidelines-for-continuous-process-manufacturing)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/medical-device/new-trends-in-guidelines-for-continuous-process-manufacturing&title=New%20Trends%20in%20Guidelines%20for%20Continuous%20Process%20Manufacturing&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/Continuous%20Manufacturing%20ICH_Site%20PQE-1.jpg&description=The%20importance%20of%20Continuous%20Manufacturing%20(CM)%20and%20its%20different%20approaches.%20The%20new%20guidelines%20and%20trends%20of%20continuous%20manufacturing%20explained.> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/medical-device/new-trends-in-guidelines-for-continuous-process-manufacturing&title=New%20Trends%20in%20Guidelines%20for%20Continuous%20Process%20Manufacturing&summary=The%20importance%20of%20Continuous%20Manufacturing%20(CM)%20and%20its%20different%20approaches.%20The%20new%20guidelines%20and%20trends%20of%20continuous%20manufacturing%20explained.> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=New%20Trends%20in%20Guidelines%20for%20Continuous%20Process%20Manufacturing&url=https://blog.pqegroup.com/medical-device/new-trends-in-guidelines-for-continuous-process-manufacturing)

[Medical Device ![](https://blog.pqegroup.com/hubfs/EU%20transitional%20periods%20MD%20IVD_site%20banner%20(1).jpg)](https://blog.pqegroup.com/medical-device/regulation-of-the-european-parliament-extension-ivd-class-3)

13 Feb 2023

## [New Extension on the Regulation of MD and IVD Transition Periods The European Commission proposed to extend the certification period for medical device suppliers by 4 years to avoid shortages. Are you compliant?](https://blog.pqegroup.com/medical-device/regulation-of-the-european-parliament-extension-ivd-class-3)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/medical-device/regulation-of-the-european-parliament-extension-ivd-class-3&title=New%20Extension%20on%20the%20Regulation%20of%20MD%20and%20IVD%20Transition%20Periods&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/EU%20transitional%20periods%20MD%20IVD_site%20banner%20%281%29.jpg&description=The%20European%20Commission%20proposed%20to%20extend%20the%20certification%20period%20for%20medical%20device%20suppliers%20by%204%20years%20to%20avoid%20shortages.%20Are%20you%20compliant> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/medical-device/regulation-of-the-european-parliament-extension-ivd-class-3&title=New%20Extension%20on%20the%20Regulation%20of%20MD%20and%20IVD%20Transition%20Periods&summary=The%20European%20Commission%20proposed%20to%20extend%20the%20certification%20period%20for%20medical%20device%20suppliers%20by%204%20years%20to%20avoid%20shortages.%20Are%20you%20compliant> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=New%20Extension%20on%20the%20Regulation%20of%20MD%20and%20IVD%20Transition%20Periods&url=https://blog.pqegroup.com/medical-device/regulation-of-the-european-parliament-extension-ivd-class-3)

[Medical Device ![](https://blog.pqegroup.com/hubfs/Clinical%20trials_Alberto%20Colombo_Site%20Banner.jpg)](https://blog.pqegroup.com/medical-device/clinical-trials-manage-regulatory-assessments)

07 Feb 2023

## [Clinical Trials Involving Medical Devices and Medicinal Products How can we best manage regulatory assessments? Here is three explanatory cases related to medicinal product clinical trials involving medical devices.](https://blog.pqegroup.com/medical-device/clinical-trials-manage-regulatory-assessments)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/medical-device/clinical-trials-manage-regulatory-assessments&title=Clinical%20Trials%20Involving%20Medical%20Devices%20and%20Medicinal%20Products&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/Clinical%20trials_Alberto%20Colombo_Site%20Banner.jpg&description=How%20can%20we%20best%20manage%20regulatory%20assessments?%20%20Here%20is%20three%20explanatory%20cases%20related%20to%20medicinal%20product%20clinical%20trials%20involving%20medical%20devices.> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/medical-device/clinical-trials-manage-regulatory-assessments&title=Clinical%20Trials%20Involving%20Medical%20Devices%20and%20Medicinal%20Products&summary=How%20can%20we%20best%20manage%20regulatory%20assessments?%20%20Here%20is%20three%20explanatory%20cases%20related%20to%20medicinal%20product%20clinical%20trials%20involving%20medical%20devices.> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Clinical%20Trials%20Involving%20Medical%20Devices%20and%20Medicinal%20Products&url=https://blog.pqegroup.com/medical-device/clinical-trials-manage-regulatory-assessments)

[Medical Device ![](https://blog.pqegroup.com/hubfs/FDA%20Software%20Guidance%20_market%20news.jpg)](https://blog.pqegroup.com/medical-device/fda-software-guidance-medical-device)

26 Oct 2022

## [FDA Software Guidance; Should I be worried? FDA released a draft guidance: Computer Software Assurance for Production and Quality System Software. What changes could it bring?](https://blog.pqegroup.com/medical-device/fda-software-guidance-medical-device)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/medical-device/fda-software-guidance-medical-device&title=FDA%20Software%20Guidance;%20Should%20I%20be%20worried?&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/FDA%20Software%20Guidance%20_market%20news.jpg&description=FDA%20released%20a%20draft%20guidance:%20Computer%20Software%20Assurance%20for%20Production%20and%20Quality%20System%20Software.%20What%20changes%20could%20it%20bring> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/medical-device/fda-software-guidance-medical-device&title=FDA%20Software%20Guidance;%20Should%20I%20be%20worried?&summary=FDA%20released%20a%20draft%20guidance:%20Computer%20Software%20Assurance%20for%20Production%20and%20Quality%20System%20Software.%20What%20changes%20could%20it%20bring> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=FDA%20Software%20Guidance;%20Should%20I%20be%20worried?&url=https://blog.pqegroup.com/medical-device/fda-software-guidance-medical-device)

[Medical Device ![](https://blog.pqegroup.com/hubfs/MDSAP%20Israel%20_banner%20insight.jpg)](https://blog.pqegroup.com/medical-device/israel-mdsap-affiliate-membership)

13 Sep 2022

## [Israel MDSAP Affiliate Membership The Ministry of Health of Israel has just been included in the Medical Device Single Audit Program (MDSAP), what are the changes?](https://blog.pqegroup.com/medical-device/israel-mdsap-affiliate-membership)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/medical-device/israel-mdsap-affiliate-membership&title=Israel%20MDSAP%20Affiliate%20Membership&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/MDSAP%20Israel%20_banner%20insight.jpg&description=The%20Ministry%20of%20Health%20of%20Israel%20has%20just%20been%20included%20in%20the%20Medical%20Device%20Single%20Audit%20Program%20(MDSAP),%20what%20are%20the%20changes> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/medical-device/israel-mdsap-affiliate-membership&title=Israel%20MDSAP%20Affiliate%20Membership&summary=The%20Ministry%20of%20Health%20of%20Israel%20has%20just%20been%20included%20in%20the%20Medical%20Device%20Single%20Audit%20Program%20(MDSAP),%20what%20are%20the%20changes> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Israel%20MDSAP%20Affiliate%20Membership&url=https://blog.pqegroup.com/medical-device/israel-mdsap-affiliate-membership)

[Medical Device ![](https://blog.pqegroup.com/hubfs/banner%20insghits%20-%20FDA%E2%80%99s%20Breakthrough%20Device%20Designation%2c%20Expediting%20Your%20Pathway%20to%20Market_1.jpg)](https://blog.pqegroup.com/medical-device/fda-breackthrough-device-designation)

07 Jul 2022

## [FDA’s Breakthrough Device Designation, Expediting Your Pathway to Market The US Breakthrough Device Designation Program can help your company speeding up your Medical Devices development, assessment and review.](https://blog.pqegroup.com/medical-device/fda-breackthrough-device-designation)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/medical-device/fda-breackthrough-device-designation&title=FDA’s%20Breakthrough%20Device%20Designation,%20Expediting%20Your%20Pathway%20to%20Market&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/banner%20insghits%20-%20FDA%E2%80%99s%20Breakthrough%20Device%20Designation%2c%20Expediting%20Your%20Pathway%20to%20Market_1.jpg&description=The%20US%20Breakthrough%20Device%20Designation%20Program%20can%20help%20your%20company%20speeding%20up%20your%20Medical%20Devices%20development,%20assessment%20and%20review.> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/medical-device/fda-breackthrough-device-designation&title=FDA’s%20Breakthrough%20Device%20Designation,%20Expediting%20Your%20Pathway%20to%20Market&summary=The%20US%20Breakthrough%20Device%20Designation%20Program%20can%20help%20your%20company%20speeding%20up%20your%20Medical%20Devices%20development,%20assessment%20and%20review.> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=FDA’s%20Breakthrough%20Device%20Designation,%20Expediting%20Your%20Pathway%20to%20Market&url=https://blog.pqegroup.com/medical-device/fda-breackthrough-device-designation)

[Medical Device ![](https://blog.pqegroup.com/hubfs/banner%20insghits-How%20could%20the%20Medical%20Device%20User%20Fee%20Amendment%20V%20Impact%20your%20MD%20Company.jpg)](https://blog.pqegroup.com/medical-device/medical-device-user-fee-amendment-v)

30 Jun 2022

## [How could the Medical Device User Fee Amendment V Impact your MD company? MDUFA V is the latest amendment to the to the MDUFA Act, and it could bring an exceptional growth to the MD Community in the US.](https://blog.pqegroup.com/medical-device/medical-device-user-fee-amendment-v)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/medical-device/medical-device-user-fee-amendment-v&title=How%20could%20the%20Medical%20Device%20User%20Fee%20Amendment%20V%20Impact%20your%20MD%20company?&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/banner%20insghits-How%20could%20the%20Medical%20Device%20User%20Fee%20Amendment%20V%20Impact%20your%20MD%20Company.jpg&description=MDUFA%20V%20is%20the%20latest%20amendment%20to%20the%20to%20the%20MDUFA%20Act,%20and%20it%20could%20bring%20an%20exceptional%20growth%20to%20the%20MD%20Community%20in%20the%20US.> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/medical-device/medical-device-user-fee-amendment-v&title=How%20could%20the%20Medical%20Device%20User%20Fee%20Amendment%20V%20Impact%20your%20MD%20company?&summary=MDUFA%20V%20is%20the%20latest%20amendment%20to%20the%20to%20the%20MDUFA%20Act,%20and%20it%20could%20bring%20an%20exceptional%20growth%20to%20the%20MD%20Community%20in%20the%20US.> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=How%20could%20the%20Medical%20Device%20User%20Fee%20Amendment%20V%20Impact%20your%20MD%20company?&url=https://blog.pqegroup.com/medical-device/medical-device-user-fee-amendment-v)

[Medical Device ![](https://blog.pqegroup.com/hubfs/EU%20IVDR%20%E2%80%93%20Clinical%20Evidence%20and%20Performance%20Evaluation%20-%20ext.jpg)](https://blog.pqegroup.com/medical-device/eu-ivdr-clinical-evidence-performance-evaluation)

01 Jul 2021

## [EU IVDR – Clinical Evidence and Performance Evaluation The new Regulation 2017/746 for In Vitro Diagnostic medical devices has been published and the new requirements for Clinical Evidence are some of.](https://blog.pqegroup.com/medical-device/eu-ivdr-clinical-evidence-performance-evaluation)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/medical-device/eu-ivdr-clinical-evidence-performance-evaluation&title=EU%20IVDR%20–%20Clinical%20Evidence%20and%20Performance%20Evaluation&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/EU%20IVDR%20%E2%80%93%20Clinical%20Evidence%20and%20Performance%20Evaluation%20-%20ext.jpg&description=The%20new%20Regulation%202017/746%20for%20In%20Vitro%20Diagnostic%20medical%20devices%20has%20been%20published%20and%20the%20new%20requirements%20for%20Clinical%20Evidence%20are%20some%20of%20those%20of%20greatest%20importance.> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/medical-device/eu-ivdr-clinical-evidence-performance-evaluation&title=EU%20IVDR%20–%20Clinical%20Evidence%20and%20Performance%20Evaluation&summary=The%20new%20Regulation%202017/746%20for%20In%20Vitro%20Diagnostic%20medical%20devices%20has%20been%20published%20and%20the%20new%20requirements%20for%20Clinical%20Evidence%20are%20some%20of%20those%20of%20greatest%20importance.> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=EU%20IVDR%20–%20Clinical%20Evidence%20and%20Performance%20Evaluation&url=https://blog.pqegroup.com/medical-device/eu-ivdr-clinical-evidence-performance-evaluation)

[Medical Device ![](https://blog.pqegroup.com/hubfs/banner-insights-Cybersecurity-MD-1.jpg)](https://blog.pqegroup.com/medical-device/eu-mdr-2017-745-new-cybersecurity-requirements-networked-md-producers)

29 Mar 2021

## [EU MDR 2017-745: New Cybersecurity Requirements for Networked MD producers In our video, we review the most important requirements a MD company has to fulfill to achieve Compliance and ensure safety for its Medical Devices.](https://blog.pqegroup.com/medical-device/eu-mdr-2017-745-new-cybersecurity-requirements-networked-md-producers)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/medical-device/eu-mdr-2017-745-new-cybersecurity-requirements-networked-md-producers&title=EU%20MDR%202017-745:%20New%20Cybersecurity%20Requirements%20for%20Networked%20MD%20producers&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/banner-insights-Cybersecurity-MD-1.jpg&description=In%20our%20video,%20we%20review%20the%20most%20important%20requirements%20a%20MD%20company%20has%20to%20fulfill%20to%20achieve%20Compliance%20and%20ensure%20safety%20for%20its%20Medical%20Devices.> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/medical-device/eu-mdr-2017-745-new-cybersecurity-requirements-networked-md-producers&title=EU%20MDR%202017-745:%20New%20Cybersecurity%20Requirements%20for%20Networked%20MD%20producers&summary=In%20our%20video,%20we%20review%20the%20most%20important%20requirements%20a%20MD%20company%20has%20to%20fulfill%20to%20achieve%20Compliance%20and%20ensure%20safety%20for%20its%20Medical%20Devices.> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=EU%20MDR%202017-745:%20New%20Cybersecurity%20Requirements%20for%20Networked%20MD%20producers&url=https://blog.pqegroup.com/medical-device/eu-mdr-2017-745-new-cybersecurity-requirements-networked-md-producers)

[Medical Device ![](https://blog.pqegroup.com/hubfs/Cybersecurity-for-Medical-Devices-risks-and-vulnerabilities.jpg)](https://blog.pqegroup.com/medical-device/medical-devices-cybersecurity)

04 Dec 2019

## [Why MD Cybersecurity is so important Understand the reasons why nowadays Cybersecurity has become a main concern for all Medical Devices producers.](https://blog.pqegroup.com/medical-device/medical-devices-cybersecurity)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/medical-device/medical-devices-cybersecurity&title=Why%20MD%20Cybersecurity%20is%20so%20important&picture=https://f.hubspotusercontent10.net/hubfs/19575960/Cybersecurity-for-Medical-Devices-risks-and-vulnerabilities.jpg&description=Understand%20the%20reasons%20why%20nowadays%20Cybersecurity has%20become%20a%20main%20concern%20for%20all%20Medical%20Devices%20producers.> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/medical-device/medical-devices-cybersecurity&title=Why%20MD%20Cybersecurity%20is%20so%20important&summary=Understand%20the%20reasons%20why%20nowadays%20Cybersecurity has%20become%20a%20main%20concern%20for%20all%20Medical%20Devices%20producers.> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Why%20MD%20Cybersecurity%20is%20so%20important&url=https://blog.pqegroup.com/medical-device/medical-devices-cybersecurity)

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