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Strengthening Supplier Assessment in Medical Devices: Best Practices for Quality, Compliance, and Risk Mitigation

by Syrma Johari MedTech | Oct 23, 2025 | Blog

In today’s high-stakes MedTech landscape, your supplier network directly reflects your product integrity, regulatory posture, and time-to-market reliability. For manufacturers of Class II and III devices, supplier non-conformance can trigger far more than a CAPA. It...

Global Regulatory Submissions for Medical Devices

by Syrma Johari MedTech | Oct 16, 2025 | Blog

A practical guide to navigate complex global approval pathways for MedTech companies. Access the Full Guide Delayed time-to-market can translate directly into lost market revenue. Navigating global regulatory submissions has become a complex challenge for MedTech...

Medical Device Contract Manufacturing: How to Choose the Right Partner

by Syrma Johari MedTech | Jul 8, 2025 | Blog

Medical device original equipment manufacturers (OEMs) are relying more than ever on contract manufacturing organizations (CMOs) to manage complex and capital-intensive manufacturing. Choosing the right medical device contract manufacturer is one of the most strategic...

Outsourcing Complaint Handling of Medical Devices? Regulatory Risks and How to Stay in Control

by Syrma Johari MedTech | Jun 16, 2025 | Blog

The medical device industry is an arena where patient safety, ethical responsibility, and precision engineering converge. High-stakes medical innovation demands rigorous compliance and intense regulatory scrutiny. Therefore, a single complaint can trigger a cascade of...

7 Key Questions to Ask Before Choosing a Medical Device Contract Manufacturer

by Syrma Johari MedTech | Apr 30, 2025 | Blog

Choosing the right contract manufacturing partner is one of the most critical decisions a medical device Original Equipment Manufacturer (OEM) will make. Today, many OEMs rely on Contract Manufacturing Organizations (CMOs) and Contract Design and Manufacturing...

Why Proactive Component Obsolescence Management Is Critical for Medical Device Manufacturers

by Syrma Johari MedTech | Apr 10, 2025 | Blog

In the fast-evolving world of electronics, component obsolescence is an inevitable challenge—especially in the medical device industry, where product lifecycles often outlast those of the individual electronic components used in their design. What Is Component...
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  • Strengthening Supplier Assessment in Medical Devices: Best Practices for Quality, Compliance, and Risk Mitigation
  • Global Regulatory Submissions for Medical Devices
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