Operon Strategist – Page 11 – Operon Strategist

Ensuring Safety and Quality: Global Regulations for Dental Cement Manufacturing

An Overview – Dental Cement Manufacturing Dental cement plays a crucial role in modern dentistry, serving as a key material for luting, lining, and restorative applications. The manufacturing of dental cement involves stringent quality control measures to ensure safety, durability, and effectiveness. Given its direct application in the oral cavity, regulatory authorities impose strict guidelines […]

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Decoding IEC 62304 Software Safety Classification: What You Need to Know

Mastering IEC 62304 software safety classification: Key Insights for Compliance and Risk Management When developing medical device software, safety is paramount. Enter IEC 62304, an international standard designed to guide the development and maintenance of software used in medical devices. Whether you’re just starting or refining an existing project, understanding how to apply IEC 62304’s

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Malaysia Medical Device Registration

An Overview – Malaysia Medical Device Registration Medical device registration in Malaysia is a crucial step for businesses that want to import or manufacture medical devices. Without necessary registrations and approvals, you cannot conduct your business operations in the country. In this article, we will walk you through Malaysia’s regulatory framework, mandatory requirements for the

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10 Essential Strategies for Effective Post-Market Surveillance under EU-MDR

10 Essential Strategies for Effective Post-Market Surveillance under EU-MDR Post-Market Surveillance (PMS) under EU-MDR is a cornerstone of ensuring medical device compliance and safety. It plays a vital role in maintaining the safety, performance, and efficacy of medical devices after they have been placed on the market. Below, we explore Post-Market Surveillance under MDR in

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10 Key Steps to Achieve EU AI Act Compliance for Medical Device

EU AI Act Compliance: Understanding the AI Act and Its Impact on Healthcare EU AI Act compliance marks a monumental shift in how artificial intelligence is regulated across industries, especially in healthcare. As of August 1, 2024, the European Union’s AI Act became the first comprehensive regulation aimed at governing AI technologies globally. This new

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Beyond MDR and IVDR: 6 Critical Regulations Shaping Medical Device Compliance

Overview – 6 Critical Regulations Shaping Medical Device Compliance In the rapidly evolving world of medical device development, regulatory compliance is the bedrock of success. Identifying and adhering to all applicable regulations ensures safety, efficacy, and market acceptance. However, the complexity of regulations can be overwhelming, especially with the introduction of stringent frameworks like the

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Centre to Reclassify Medical Devices to Streamline Regulation and Boost Sector Growth

Overview: Center to Reclassify Medical Devices New Delhi: In a significant move towards ensuring regulatory uniformity in the medical device sector, the government plans to reclassify approximately 1,178 medical devices into four categories based on their risk profile, under the Medical Device Rule (MDR), 2017. The Central Drugs Standards Control Organization (CDSCO) is revising the

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CDSCO Seeks Industry Feedback on Updated Medical Device Classification List

CDSCO Updates Classification List for Four Medical Device Categories, Invites Stakeholder Feedback The Central Drugs Standard Control Organisation (CDSCO) has announced an updated classification list for medical devices, spanning four categories: interventional radiology, radiotherapy, oncology, and Class A (non-sterile and non-measuring) medical devices. This revision follows the Medical Device Rules (MDR), 2017, as well as

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USFDA Releases Draft Guidance for AI-Enabled Medical Devices

USFDA Draft Guidance for AI-Enabled Medical Devices The U.S. Food and Drug Administration (FDA) has released draft guidance aimed at supporting the development and marketing of safe and effective AI-enabled medical devices throughout their Total Product Life Cycle. Once finalized, this would be the first comprehensive guidance providing recommendations for every phase of AI-enabled device

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PLI Scheme Medical Device Sales Boost to Rs 8,039.63 Crore in India

An Overview – PLI Scheme Medical Device Sales Medical device manufacturers in India have achieved impressive sales of Rs 8,039.63 crore under the Production Linked Incentive (PLI) Scheme as of September 2024. This includes exports worth Rs 3,844.01 crore, highlighting the global reach of India’s medical devices industry. The PLI Scheme for Medical Devices, approved

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