Operon Strategist

Transdermal Patches

Transdermal Patches: A Growing Drug-Device Combination Opportunity

Introduction Transdermal patches have emerged as one of the most innovative drug delivery systems in modern healthcare. These patches deliver therapeutic agents through the skin directly into the bloodstream, providing a non-invasive and controlled alternative to oral or injectable medications. As a result, they are increasingly being adopted for the treatment of chronic conditions such […]

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Custom-Made Medical Devices

Custom-Made Medical Devices under EU MDR: A Complete Guide for Manufacturers

If you manufacture custom-made medical devices, navigating the European Union’s Medical Device Regulation (EU MDR 2017/745) is essential for compliance and continued market access. These devices are tailor-made to meet individual patient needs but must still meet strict EU safety, performance, and documentation requirements. Gain a clear understanding of what qualifies as custom made medical

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CDSCO Medical Device Alert

CDSCO Medical Device Alert: New Auto-Generated Workflow Requires Re-Submission

CDSCO Medical Device Division Updates Application Process — Fresh Submissions Now Mandatory for MSC and NCC India’s medical device industry is seeing a notable shift in compliance procedures. The CDSCO medical device division has rolled out an upgraded online system for issuing two critical certificates — the Market Standing Certificate (MSC) and the Non-Conviction Certificate

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USTR

Update: Clarifying USTR Claims on India’s Medical Device Policy

Overview: USTR’s Claims and India’s Medical Device Policy Response The United States Trade Representative (USTR), in its 2025 National Trade Estimate (NTE) report, raised concerns about India’s regulatory environment for medical devices. According to the USTR, high import tariffs, strict price controls, and restrictions on refurbished devices are acting as barriers for U.S. exporters. While

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GSPR Checkllist

GSPR Checklist 2025: What’s Changed and What Still Matters

GSPR Checklist 2025: Key Compliance Updates for Medical Device Manufacturers For medical device manufacturers navigating the EU market, the GSPR checklist is more than just a regulatory formality—it is the foundation of EU MDR compliance. With 2025 underway, updated interpretations and emerging expectations have made it essential to reassess the GSPR checklist with fresh eyes

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ISO 13485 Design Changes

ISO 13485 Design Changes: Ensuring Compliance with FDA and Global Regulations

How to Manage ISO 13485 Design Changes in Medical Devices and Stay Compliant? Changes in medical device design, manufacturing processes, or regulatory requirements are inevitable. Whether your company is a startup or an established manufacturer, effective change control is crucial to ensure compliance with ISO 13485 design changes and FDA 21 CFR Part 820.30(i). Without

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PRRC under EU MDR and IVDR

PRRC Under EU MDR & IVDR: Everything You Need to Know

Are You EU MDR/IVDR Compliant? The PRRC Role Explained The Person Responsible for Regulatory Compliance (PRRC) plays a crucial role in ensuring compliance with the Medical Device Regulation (MDR) (EU 2017/745) and In Vitro Diagnostic Regulation (IVDR) (EU 2017/746). This mandatory position safeguards regulatory integrity and ensures medical devices meet EU compliance standards. What is

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India's First Indigenous MRI Machine Ready to Reshape Healthcare

India’s First Indigenous MRI Machine Ready to Reshape Healthcare

India’s First Indigenous MRI Machine Set to Lower Treatment Costs and Boost Self-Reliance India has successfully developed its first indigenous MRI machine, a major step toward self-reliance in medical technology. The 1.5 Tesla MRI scanner is scheduled for installation at AIIMS Delhi by October for trial runs. This initiative aims to reduce healthcare costs and

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FDA Breakthrough Device Designation

FDA Breakthrough Device Designation: Accelerating Medical Innovation

Bringing innovative medical devices to market is a long and complex process. For devices targeting life-threatening or irreversibly debilitating conditions, time is of the essence. That’s where the FDA Breakthrough Devices Program comes in. This blog explores what the Breakthrough Device Designation is, who qualifies, and how it helps innovators fast-track their regulatory journey in

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