--- title: Blog | Medical Device description: Medical Device | Stay updated on Life Science through expert insights, industry trends, latest news and more with PQE Group's blog. --- [![Logo PQE Group - azzurro - 2024](https://blog.pqegroup.com/hs-fs/hubfs/Logo%20PQE%20Group%20-%20azzurro%20-%202024.png?width=2000&height=721&name=Logo%20PQE%20Group%20-%20azzurro%20-%202024.png "Logo PQE Group - azzurro - 2024")](https://www2.pqegroup.com) - [Home](https://www2.pqegroup.com/) - [Industry](https://www2.pqegroup.com/industry/) - [Pharma & API](https://www2.pqegroup.com/pharma-api/) - [Medical Device](https://www2.pqegroup.com/medical-device/) - [Biotech](https://www2.pqegroup.com/biotech/) - [Startup](https://www2.pqegroup.com/startup/) - [Veterinary](https://www2.pqegroup.com/veterinary/) - [Services](https://www2.pqegroup.com/services/) - [Data Integrity](https://www2.pqegroup.com/data-integrity/) - [Digital Governance](https://www2.pqegroup.com/digital-governance/) - [Engineering](https://www2.pqegroup.com/engineering/) - [Commissioning, Qualification and Validation (CQV)](https://www2.pqegroup.com/commissioning-qualification-validation/) - [Quality Compliance](https://www2.pqegroup.com/quality-compliance/) - [Laboratory Excellence](https://www2.pqegroup.com/laboratory-excellence/) - [Regulatory Affairs](https://www2.pqegroup.com/regulatory-affairs/) - [Audits](https://www2.pqegroup.com/audits/) - [Training](https://www2.pqegroup.com/training/) - [Clinical Research](https://www2.pqegroup.com/clinical-research-services/) - [Pharmacovigilance](https://www2.pqegroup.com/pharmacovigilance/) - About - [About Us](https://www2.pqegroup.com/about/) - [ESG](https://www2.pqegroup.com/about/csr/) - [Women in STEM](https://www2.pqegroup.com/about/women-in-stem/) - Resources - [News & Press](https://www2.pqegroup.com/news/) - [Webinars](https://www2.pqegroup.com/webinars/) - [Blog](https://blog.pqegroup.com/) - [Careers](https://www2.pqegroup.com/careers/) - [Contact Us](https://www2.pqegroup.com/contact-us/) [Home](https://www2.pqegroup.com/) [Blog](https://blog.pqegroup.com/) # **Latest Insights** [Medical Device ![](https://blog.pqegroup.com/hubfs/BANNER-Why%20Your%20Software%20as%20a%20Medical%20Device%20(SaMD)%20Development%20Should%20Take%20a%20Quality%20by%20Design%20Approach%20_1_1_1.jpg)](https://blog.pqegroup.com/medical-device/why-your-software-as-a-medical-device-samd-development-should-take-a-quality-by-design-approach) 15 Sep 2025 ## [Why Your Software as a Medical Device (SaMD) Development Should Take a Quality by Design Approach  Learn why Software as a Medical Device development needs a Quality by Design approach to ensure safety, compliance, and patient trust](https://blog.pqegroup.com/medical-device/why-your-software-as-a-medical-device-samd-development-should-take-a-quality-by-design-approach) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Why%20Your%20Software%20as%20a%20Medical%20Device%20(SaMD)%20Development%20Should%20Take%20a%20Quality%20by%20Design%20Approach &url=https://blog.pqegroup.com/medical-device/why-your-software-as-a-medical-device-samd-development-should-take-a-quality-by-design-approach) [Medical Device ![](https://blog.pqegroup.com/hubfs/Devices%20for%20Veterinary%20Use_Site%20Banner_1-1.jpg)](https://blog.pqegroup.com/medical-device-compliance/italian-guidelines-on-safety-and-performance-of-veterinary-devices) 25 Jul 2024 ## [Italian Guidelines on Safety and Performance of Veterinary Devices Discover the Italian Guidelines on Safety and Performance of Veterinary Devices, outlining key requirements for manufacturers to ensure efficacy](https://blog.pqegroup.com/medical-device-compliance/italian-guidelines-on-safety-and-performance-of-veterinary-devices) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Italian%20Guidelines%20on%20Safety%20and%20Performance%20of%20Veterinary%20Devices&url=https://blog.pqegroup.com/medical-device-compliance/italian-guidelines-on-safety-and-performance-of-veterinary-devices) [Medical Device ![](https://blog.pqegroup.com/hubfs/AI%20Medical%20Device%20Field_Site%20Banner.jpg)](https://blog.pqegroup.com/medical-device-compliance/ai-application-in-the-medical-device-field) 18 Jun 2024 ## [AI application in the Medical Device Field Explore the transformative impact of Artificial Intelligence in the medical device field, from disease detection to personalized treatment.](https://blog.pqegroup.com/medical-device-compliance/ai-application-in-the-medical-device-field) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=AI%20application%20in%20the%20Medical%20Device%20Field&url=https://blog.pqegroup.com/medical-device-compliance/ai-application-in-the-medical-device-field) [Medical Device ![](https://blog.pqegroup.com/hubfs/Ensuring%20Quality_Site%20Banner_1-1.jpg)](https://blog.pqegroup.com/medical-device-compliance/ensuring-quality-key-steps-in-medical-device-validation) 03 Jun 2024 ## [Ensuring Quality: Key Steps in Medical Device Validation Learn about the key steps in medical device validation, including process validation phases and regulatory aspects.](https://blog.pqegroup.com/medical-device-compliance/ensuring-quality-key-steps-in-medical-device-validation) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Ensuring%20Quality:%20Key%20Steps%20in%20Medical%20Device%20Validation&url=https://blog.pqegroup.com/medical-device-compliance/ensuring-quality-key-steps-in-medical-device-validation) [Medical Device ![](https://blog.pqegroup.com/hubfs/IVDR_News%20US.jpg)](https://blog.pqegroup.com/medical-device/ivds-a-comparison-of-requirements-between-the-us-and-eu) 27 May 2024 ## [IVDs – A Comparison of Requirements between the US and EU Get insights on the differences and similarities in IVD requirements between the US and EU markets.](https://blog.pqegroup.com/medical-device/ivds-a-comparison-of-requirements-between-the-us-and-eu) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=IVDs%20–%20A%20Comparison%20of%20Requirements%20between%20the%20US%20and%20EU&url=https://blog.pqegroup.com/medical-device/ivds-a-comparison-of-requirements-between-the-us-and-eu) [Medical Device ![](https://blog.pqegroup.com/hubfs/Comparison%20Between%20IVDR%20and%20MDR%20Software_Site%20Banner.jpg)](https://blog.pqegroup.com/medical-device/a-comparison-between-ivdr-and-mdr-software) 14 Feb 2024 ## [A Comparison Between IVDR and MDR Software Learn about the qualification process, classification rules, and standards that apply. Stay compliant with medical device regulations.](https://blog.pqegroup.com/medical-device/a-comparison-between-ivdr-and-mdr-software) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=A%20Comparison%20Between%20IVDR%20and%20MDR%20Software&url=https://blog.pqegroup.com/medical-device/a-comparison-between-ivdr-and-mdr-software) [Medical Device ![](https://blog.pqegroup.com/hubfs/Clinical%20Trials%20MD%20MP_Site%20Banner.jpg)](https://blog.pqegroup.com/medical-device/clinical-trials-involving-medical-devices-and-medicinal-products) 05 Dec 2023 ## [Clinical trials involving Medical Devices and Medicinal Products. How can we manage regulatory assessments? Learn how to manage regulatory assessments for clinical trials for medical devices and medicinal products. Understand different scenarios and.](https://blog.pqegroup.com/medical-device/clinical-trials-involving-medical-devices-and-medicinal-products) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Clinical%20trials%20involving%20Medical%20Devices%20and%20Medicinal%20Products.%20How%20can%20we%20manage%20regulatory%20assessments?&url=https://blog.pqegroup.com/medical-device/clinical-trials-involving-medical-devices-and-medicinal-products) [Medical Device ![](https://blog.pqegroup.com/hubfs/Medical%20Device%20Software_FDA_Site%20Banner.jpg)](https://blog.pqegroup.com/medical-device/new-fda-guidance-premarket-submission-for-software) 11 Jul 2023 ## [New FDA guidance on premarket submission for software: what happens now? New FDA's guidance providing updates on the documentation recommended for inclusion in premarket submissions for its review of device software.](https://blog.pqegroup.com/medical-device/new-fda-guidance-premarket-submission-for-software) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=New%20FDA%20guidance%20on%20premarket%20submission%20for%20software:%20what%20happens%20now?&url=https://blog.pqegroup.com/medical-device/new-fda-guidance-premarket-submission-for-software) [Medical Device ![](https://blog.pqegroup.com/hubfs/Medical%20Device%20Regulations%20EU%20vs%20USA_Site%20Banner%20(1).jpg)](https://blog.pqegroup.com/medical-device/medical-device-regulations-eu-mdr-vs-fda) 30 Jun 2023 ## [Medical Device Regulations in the EU (MDR) vs. FDA (US Food and Drug Administration) Challenges and Considerations in Launching a Medical Device in Multiple Markets. A comparison between EU (MDR) vs. FDA (US Food and Drug.](https://blog.pqegroup.com/medical-device/medical-device-regulations-eu-mdr-vs-fda) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Medical%20Device%20Regulations%20in%20the%20EU%20(MDR)%20vs.%20FDA%20(US%20Food%20and%20Drug%20Administration)&url=https://blog.pqegroup.com/medical-device/medical-device-regulations-eu-mdr-vs-fda) [Medical Device ![](https://blog.pqegroup.com/hubfs/Regulatory%20changes%20for%20MD_old%20vs%20new_Site%20Banner-1.jpg)](https://blog.pqegroup.com/medical-device/how-to-find-your-way-through-the-new-regulatory-changes-for-medical-devices-a-comparison-of-old-vs.-new) 23 Jun 2023 ## [How to Find Your Way Through the New Regulatory Changes for Medical Devices: A Comparison of Old vs. New The new European changes in the medical device regulatory scope, and the particular characteristics of the Polish law.](https://blog.pqegroup.com/medical-device/how-to-find-your-way-through-the-new-regulatory-changes-for-medical-devices-a-comparison-of-old-vs.-new) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=How%20to%20Find%20Your%20Way%20Through%20the%20New%20Regulatory%20Changes%20for%20Medical%20Devices:%20A%20Comparison%20of%20Old%20vs.%20New&url=https://blog.pqegroup.com/medical-device/how-to-find-your-way-through-the-new-regulatory-changes-for-medical-devices-a-comparison-of-old-vs.-new) [Load More](https://blog.pqegroup.com/tag/medical-device/page/2) ### Categories - 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