Operon Strategist – Page 36 – Operon Strategist

Complete Guide for 3D Printing in Medical Device Manufacturing

Revolutionizing Healthcare with 3D Printing Did you know that 3D printing is transforming the medical device industry by enabling customized implants, prosthetics, and surgical tools? With its ability to create complex, patient-specific designs at a lower cost, 3D printing is paving the way for groundbreaking advancements in healthcare. What is 3D Printing in Medical Device […]

Complete Guide for 3D Printing in Medical Device Manufacturing Read More »

Nephrology and Renal Care Devices-01.jpg

Advancements in Nephrology and Renal Care Devices

What is Nephrology and Renal Care Devices in India? Nephrology and renal care are fields that are rapidly developing. The way kidney disorders are identified, followed up on, and treated is transforming, thanks to developments in technology and medicine. Patients now have access to a far greater variety of nephrology and renal care devices in

Advancements in Nephrology and Renal Care Devices Read More »

Consequences of Non-compliance with ISO 13485 for Medical Device Manufacturers

ISO 13485:2016 Quality Management System ISO 13485:2016 is the standard for a Quality Management System (“QMS”) for the design and manufacture of Medical Devices. While ISO 13485:2016 remains a stand-alone document, it aligns with ISO 9001:2008. ISO 13485 evaluates whether your Quality Management System is appropriate and effective while emphasizing the safety and efficacy of

Consequences of Non-compliance with ISO 13485 for Medical Device Manufacturers Read More »

The Complete Guide to MRI Machine Manufacturing: Processes & Innovations

What is an MRI Machine? An MRI machine uses strong magnets and radio waves to create detailed images of the body’s organs and tissues. Unlike CT scans or X-rays, it’s a safer option because it doesn’t use harmful radiation. MRI provides clear, cross-sectional images of the body’s internal structures, making it an essential tool in

The Complete Guide to MRI Machine Manufacturing: Processes & Innovations Read More »

Respiratory Medical Devices and Regulatory Compliance

Control Drug Standard Central Organisation (CDSCO) is India’s regulatory body regulating medical device regulatory affairs and registration in India. The main aim of the CDSCO is to register the manufacturer and importers who want to sell and distribute medical devices in India in accordance with medical device regulatory affairs. On 6th Aug 2021, under the

Respiratory Medical Devices and Regulatory Compliance Read More »

Anesthesiology Medical Devices Regulations and Approvals

Anesthesiology medical devices are critical components of patient care in surgical procedures and medical treatments. These devices help to control pain, manage breathing and circulation, and monitor vital signs, ensuring that patients remain safe and comfortable throughout their procedures. In order to ensure the safety and efficacy of these devices, they are subject to a

Anesthesiology Medical Devices Regulations and Approvals Read More »

UKCA vs CE: How New Regulations Affected the Manufacturing of Medical Devices

So, after Brexit, both the United Kingdom and the European Union came up with their conformity marking certificates. The United Kingdom opted for United Kingdom Conformity Assessed, whereas the European Union came up with Conformité Européenne, the French word for European conformity. The CE mark applies to all the 27 member states of the European

UKCA vs CE: How New Regulations Affected the Manufacturing of Medical Devices Read More »

Hybrid Audits For Medical Devices

During COVID-19, there was lots of disruption in the world, which changed how things used to work. Due to travel restrictions and lockdowns to stop the virus from spreading, people shifted their work to online from offline mode. Information technology use reached its high time usage due to its high demand, as this was the

Hybrid Audits For Medical Devices Read More »

Oncology Medical Devices Manufacturing and Regulatory Compliance

What is oncology and oncology medical device? Cancer is one of the deadliest and most spread diseases in India and worldwide. India is in 3rd position in terms of cancer patients; as per the National Cancer Registry Program report, approximately 13 lakh people have cancer every year. According to the Indian Council of Medical research,

Oncology Medical Devices Manufacturing and Regulatory Compliance Read More »

Amendment to EN ISO 13485:2016

What is EN ISO 13485? Implementing and maintaining a strong quality management system (QMS) for your medical devices, products, and services is critical to the success of your company. Your QMS’s EN ISO 13485 certification displays your dedication to working at a worldwide level. As ISO 13485 medical device consultant we assist our clients in

Amendment to EN ISO 13485:2016 Read More »