# MedLaunch
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## Pages
- [Service Areas](https://www.medlaunch.tech/service-areas/)
- [Medical Device AI & Cybersecurity Regulatory Compliance](https://www.medlaunch.tech/services/medical-device-ai-cybersecurity-regulatory-compliance/)
- [Compliance](https://www.medlaunch.tech/compliance/)
- [Schedule a Consultation](https://www.medlaunch.tech/schedule-a-consultation/)
- [Accessibility Notice](https://www.medlaunch.tech/accessibility-notice/)
- [About Us](https://www.medlaunch.tech/mission-vision-and-core-values/)
- [ISO 10993: Biocompatibility](https://www.medlaunch.tech/compliance/iso-10993-compliance/)
- [IEC 62304: Software Development](https://www.medlaunch.tech/compliance/iec-62304-compliance/)
- [Reviews](https://www.medlaunch.tech/reviews/)
- [ISO 14971: Risk Management](https://www.medlaunch.tech/compliance/iso-14971-compliance/)
- [21 CFR 820: FDA Quality System](https://www.medlaunch.tech/compliance/21-cfr-820-compliance/)
- [Terms & Conditions](https://www.medlaunch.tech/terms-and-conditions/)
- [Privacy Policy](https://www.medlaunch.tech/privacy-policy/)
- [Extending Shelf-Life from 6 Months to 5 Years for a Medical Startup's Innovative Device](https://www.medlaunch.tech/case-studies/extending-medical-device-shelf-life/)
- [IEC 60601: Medical Electrical Equipment](https://www.medlaunch.tech/compliance/iec-60601/)
- [ISO 13485: Quality Management](https://www.medlaunch.tech/compliance/iso-13485-compliance/)
- [IEC 62366-1: Usability Engineering](https://www.medlaunch.tech/compliance/iec-62366-1-compliance/)
- [Product & Process Development](https://www.medlaunch.tech/services/product-development/)
- [Project Management & PMO](https://www.medlaunch.tech/services/project-management-and-pmo/)
- [Labeling, UDI, ISO 15223-1,
21 CFR 801](https://www.medlaunch.tech/compliance/medical-device-labeling-udi/)
- [Regulatory Compliance](https://www.medlaunch.tech/services/regulatory-compliance-fda-eu-mdr/)
- [Contract Manufacturing](https://www.medlaunch.tech/services/contract-manufacturing/)
- [Testing & Validation](https://www.medlaunch.tech/services/testing-and-validation/)
- [EU MDR 2017/745](https://www.medlaunch.tech/compliance/eu-mdr-2017-745-compliance/)
- [Revitalizing a Legacy Medical Device](https://www.medlaunch.tech/case-studies/revitalizing-legacy-medical-device/)
- [FAQs](https://www.medlaunch.tech/faqs/)
- [Quality Management Systems (QMS)](https://www.medlaunch.tech/services/quality-systems/)
- [Our Team](https://www.medlaunch.tech/about-us/)
- [Case Studies: Discover the
MedLaunch Difference](https://www.medlaunch.tech/case-studies/)
- [Home](https://www.medlaunch.tech/)
- [Blog](https://www.medlaunch.tech/blog/)
- [Contact Us](https://www.medlaunch.tech/contact-us/)
- [Our Services](https://www.medlaunch.tech/services/)
- [Thank You](https://www.medlaunch.tech/thank-you/)
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## Posts
- [What Is ISO/IEC 42001 and Why Does It Matter for AI Compliance?](https://www.medlaunch.tech/what-is-iso-iec-42001-and-why-does-it-matter-for-ai-compliance/)
- [Navigating FDA's New Draft Guidance on AI-Enabled Device Software Functions](https://www.medlaunch.tech/fda-ai-draft-guidance/)
- [Revolutionizing Mammography with AI/ML: Promise and Pitfalls](https://www.medlaunch.tech/revolutionizing-mammography-with-ai-ml-promise-and-pitfalls/)
- [Ethical AI Research and the Future of FDA Medical Device Compliance](https://www.medlaunch.tech/ethical-ai-research-and-the-future-of-fda-medical-device-compliance/)
- [Regulatory Nuances in Emerging Technologies: What You Need to Know about AI in Medical Devices](https://www.medlaunch.tech/regulatory-nuances-in-emerging-technologies-what-you-need-to-know-about-ai-in-medical-devices/)
- [NEWS: New Study Highlights AI-Related Safety Challenges in FDA Medical Device Reports](https://www.medlaunch.tech/news-new-study-highlights-ai-related-safety-challenges-in-fda-medical-device-reports/)
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