Operon Strategist

Clean Room Classification for Injection Molding and Assembly

Medical Device Clean Room Classification for Injection Molding and Assembly

Clean Room Classification for Injection Molding and Assembly – Overview If you are an aspiring business owner who wants to manufacture medical devices, then it is essential to have the right clean room classification for medical device injection molding and assembly. The ideal environment for your product will depend on the kind of medical device […]

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EU Declaration of Conformity for Medical Devices

EU Declaration of Conformity for Medical Devices: All You Need to Know

What is an EU Declaration of Conformity (DoC)? EU Declaration of Conformity (DoC) formally known as the CE Declaration of Conformity is a mandatory one-page letter or document showing that the product’s compliance with the CE marking directives or regulations applicable to EU Law. If the Manufacturer or the Authorized Representative signs the EU Declaration of

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testing labs for medical devices

MoH Directs State Govt to Establish Testing Labs for Medical Devices

Testing Labs for Medical Devices – Latest News The Health Ministry issued a final notification revising the MDR, 2017. It has introduced new sub-rules that define the establishment of state medical device testing laboratories. Operon Strategist stays on top of all the recent medical device industry updates. Subscribe to our Newsletter for all the updates.

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Opportunities for Global Manufacturers

India is Unlocking Opportunities for Global Manufacturers

Operon Strategist, a leading medical device consultancy, is excited to share the recent developments in the Indian medical devices sector as conveyed by Dr. Mansukh Mandaviya, the Union Minister of Health & Family Welfare.   He emphasized the importance of the medical devices sector in India’s healthcare system. Dr. Mandaviya stated that the Indian medical devices

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GMP certificate for medical devices

GMP Certificate Standards and Guidance for Medical Devices

GMP Certificate for Medical Devices – An Overview In the United States, the Food and Drug Administration (FDA) creates regulations that govern the sale of food, drugs, biologics, and medical devices. The FDA mandates manufacturers in these industries to establish and maintain quality systems to ensure that their products meet their customers’ usability and safety

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Ophthalmic Medical Devices

The Importance of CE Marking for Ophthalmic Medical Devices

The Importance of CE Marking for Ophthalmic Medical Devices Ophthalmic medical devices are specialized instruments or equipment used to diagnose, treat, or manage eye-related conditions or diseases.  An Overview: Ophthalmic medical devices play a critical role in diagnosing, treating, and managing eye-related conditions and diseases. In the European market, there is a high demand for

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Clinical Investigations of Medical Devices: A Brief Guide to Essential Documents

Any investigation aiming to verify the clinical performance, clinical benefit, clinical safety and/or any undesirable side effects of a medical device is considered a clinical investigation of that device. It is One of the time and resource intensive challenges that manufacturers of medical devices may face.  Clinical investigation is defined as any systematic investigation involving one

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