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Medical Device Cybersecurity Practices

Medical Device Cybersecurity Practices: Essential Steps for Device Safety

Securing Medical Device Cybersecurity Practices In today’s connected world, cybersecurity for medical devices is more crucial than ever. With advanced networked capabilities, these devices face unique threats that could potentially compromise patient safety and data integrity. Recognizing these risks, the FDA has intensified its focus on medical device cybersecurity, encouraging manufacturers to implement proactive measures […]

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List of Refurbished Medical Equipment

Centre Releases Revised List of Refurbished Medical Equipment for High-End Imports

Centre Approves Revised List of Refurbished Medical Equipment for Import The Centre has announced a revised list of refurbished medical equipment approved for import, which now includes high-end devices such as MRI, CT, PET-CT, and various radiography devices. This 38-item list has been issued by the Union Ministry of Environment, Forest, and Climate Change (MoEFCC)

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EU Urges Urgent MDR and IVDR

EU Urges Urgent MDR and IVDR Revision for Innovation and SMEs

EU MDR and IVDR Regulation Revision The European Parliament has adopted a resolution emphasizing the “Urgent need to revise the medical devices regulation (MDR/IVDR).” This move addresses the growing challenges faced by the medical device industry, with a focus on balancing innovation with patient safety. Learn More About GSPR Requirements for EU MDR and IVDR    Looking

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Understanding of Harmonized Standards: Your Guidance to European CE Marking Compliance

CE Marking Compliance with Harmonized Standards: An Overview In the world of medical devices, ensuring compliance with the strict regulations governing their development and market entry is crucial. At the heart of this process is CE marking, mandatory symbol that signifies conformity with essential safety and performance requirements outlined in the EU Medical Device Regulation

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FDA Regulatory Pathways for New Medical Devices

FDA Regulatory Pathways for New Medical Devices (Innovative): Navigating 510(k), De Novo and PMA Processes

Overview of FDA Regulatory Pathways for New Medical Devices As the regulatory landscape in the UK and EU undergoes significant changes, many medical device manufacturers are shifting their focus to the U.S. market. For those unfamiliar with the U.S. regulatory environment, gaining FDA approval for medical devices may seem like a daunting task. However, understanding

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7 Must-Have QMS SOPs Every Medical Device Start-up Needs to Implement Early

QMS SOPs Every Medical Device Start-up Needs to Impement Early Starting a medical device company is an exciting journey, but it comes with stringent regulatory requirements that must be met to ensure product quality and patient safety. A well-structured medical device Quality Management System (QMS) is the foundation for achieving compliance with international standards like

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Declaration of Conformity

Understanding the Creation of a Declaration of Conformity (DoC) for Medical Devices

Overview of Declaration of Conformity Creating a Declaration of Conformity (DoC) is a critical step for medical device manufacturers when entering the European market under the Medical Device Regulation (MDR). While this document might seem like just another formality, it holds legal weight as it confirms that the device complies with all applicable EU regulations.

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MvPI releases updated version of medical devices adverse event reporting form

MvPI Releases Updated Version of Medical Devices Adverse Event Reporting Form

MvPI Releases Updated Version The Materiovigilance Programme of India (MvPI), under the Indian Pharmacopoeia Commission (IPC), has released an updated version of the medical device adverse event reporting form for manufacturers, importers, distributors, and healthcare professionals. This revision aligns with the central government’s efforts to encourage timely reporting of adverse events associated with medical devices.

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India Rejects Clinical Trial Waivers for In-Vitro Diagnostics Despite International Approvals

India Rejects Clinical Trial Waivers for In-Vitro Diagnostics Despite International Approvals

India Rejects Clinical Trial Waivers for In-Vitro Diagnostics New Delhi: The Indian government has resolved not to grant clinical trial waivers for In-Vitro Diagnostics (IVDs), even if these devices have been approved in other developing nations. IVDs are medical devices that test samples taken from the body to diagnose diseases, conditions, or infections. This decision

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