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When to Submit a USFDA 510(k)

When to Submit a USFDA 510(k): Timing Your FDA Application Strategically

Understanding the US FDA 510(k) Submission Process The US FDA 510(k) submission is a vital regulatory requirement for manufacturers planning to market moderate-risk (Class II) medical devices in the United States. Submitting a well-prepared 510(k) not only ensures compliance with the US FDA but also helps gain a competitive edge, ensures patient safety, and accelerates […]

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Wearable Defibrillators Manufacturing

Wearable Defibrillators Manufacturing Process and Regulatory Requirements

Introduction Cardiovascular diseases are the leading cause of death worldwide, and India is no exception. As the burden of heart conditions continues to grow, innovative solutions like wearable defibrillators are gaining significant traction. These life-saving medical devices monitor patients at risk of sudden cardiac arrest and deliver a therapeutic shock when necessary.  If you’re a medical device manufacturer

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UCMPMD Guidelines

UCMPMD Guidelines: How to File Self-Declaration & Marketing Expenditure Disclosure

If you’re part of the medical device industry in India, you’ve likely come across the term UCMPMD Guidelines. These guidelines were introduced to promote transparency and ethical marketing practices within the medical device sector. Every medical device company is expected to file a self-declaration and disclose their marketing expenditure regularly. But what does this actually

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Medical Device Quality Assurance

A Guide to Medical Device Quality Assurance

Introduction: Why Medical Device Quality Assurance Matters In today’s rapidly evolving healthcare industry, the role of medical devices is more critical than ever. From basic diagnostic tools to life-sustaining equipment, these devices directly impact patient health and outcomes. To maintain safety, performance, and regulatory compliance, Medical Device Quality Assurance (QA) plays a vital role across

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Clinical Trial Management

Mistakes to Avoid in Medical Device Clinical Trial Management and How to Fix Them

Introduction to Clinical Trial Conducting a clinical trial is a pivotal step in the development of any medical device. A successful trial ensures the device’s safety and effectiveness, facilitates regulatory approvals, and builds credibility with healthcare providers and patients. However, Clinical Trial Management for medical devices is a complex and resource-intensive process that leaves no room for

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CE Mark and EU-MDR

Facilitating CE Mark and EU-MDR Compliance for Medical Device Turnkey Plant Projects

How to Ensure CE Mark and EU MDR Compliance in Turnkey Plant Setup? Meeting CE Mark certification and EU Medical Device Regulation (MDR) requirements is crucial for any medical device manufacturer entering the European Union (EU) market. These regulations ensure devices meet strict safety, performance, and quality standards before being made available in Europe.  A

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Medical Devices

Kerala Set to Emerge as Global Hub for Medical Devices and Ancillary Industries Within 5 Years: Dr. Satheesh Kumar

A State on the Rise in the Medtech Ecosystem Kerala, traditionally behind in pharmaceutical production, is quickly evolving into a powerhouse in the medical device manufacturing sector. Dr. C.S. Satheesh Kumar, former Drug Controller of Kerala and now Corporate Communication Head at Agappe Diagnostics, asserts that the Kerala medical device industry will become globally competitive

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Import Duty

EU Pushes India for Major Import Duty Cuts on Medical Devices Under FTA Talks

The European Union (EU) is urging India to significantly reduce or eliminate import duties on medical devices as part of the ongoing negotiations for a comprehensive India-EU Free Trade Agreement (FTA). This demand is part of the EU’s broader objective to enhance market access across key sectors, including medical devices, automobiles, wines, and spirits. Current

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Notified Bodies

Notified Bodies for Medical Devices: What You Need to Know

Introduction When navigating the complex regulatory landscape of medical device manufacturing in the European Union, one term you’ll frequently encounter is Notified Bodies. These organizations play a critical role in ensuring that medical devices meet the required safety, performance, and quality standards before they can be sold in the EU. Whether you’re a medical device

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