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Important Update: CDSCO Requires Mandatory Registration for Class C and D Medical Devices with Transition to Licensing | Operon Strategist

The Central Drugs Standard Control Organization (CDSCO) in India has recently announced a significant update regarding the registration and licensing...

Performance evaluation is a crucial step in the development and validation of in vitro diagnostic (IVD) devices. It ensures that...

BD, a global medical technology company, has recently announced its expansion of access to advanced image-enabled, spectral cell sorters. This...

Greenlight Guru Clinical is a leading provider of quality management software for the medical technology industry. Their platform offers a...

Greenlight Guru, a leading provider of quality management software specifically designed for the medical device industry, has once again proven...

Managing budgets and meeting milestones are crucial aspects of conducting successful clinical investigations in the field of medical technology (MedTech)....

The National Medical Products Administration (NMPA) in China has been busy in April 2024, with several important updates and developments...

The Food and Drug Administration (FDA) has recently announced that it will be clearing Bluetooth medical devices for use in...

The Food and Drug Administration (FDA) has recently announced that it will be clearing the use of Bluetooth technology in...

The National Medical Products Administration (NMPA) recently issued a new guideline aimed at improving usability engineering in medical devices. This...

The National Medical Products Administration (NMPA) in China recently issued a new guideline for usability engineering in medical devices. This...

As the global healthcare industry continues to expand, medical device manufacturers are increasingly looking to explore international markets for growth...

As the global healthcare industry continues to expand, medical device manufacturers are increasingly looking to explore international markets to tap...

Sequana Medical, a leading medical device company focused on the development of innovative solutions for the management of fluid overload...

Introduction ISO 13485:2016 and Part 820.25 are two important standards that govern the quality management systems of medical device manufacturers....

Healthcare cloud computing has revolutionized the way medical devices are managed and operated in the healthcare industry. By utilizing cloud-based...

BioCardia, a leading biotechnology company focused on the development of innovative regenerative therapies for cardiovascular diseases, has recently received a...

ElectroCore, a leading bioelectronic medicine company, has recently been awarded a grant to further develop a groundbreaking treatment for post-traumatic...

The Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and efficacy of medical products in...

Drug-device combination products are becoming increasingly popular in the healthcare industry, offering a unique approach to treating various medical conditions....

Haryana, one of India’s leading states in terms of industrial development, has recently announced its ambitious Medical Device Manufacturing Policy...

Colorectal cancer is a type of cancer that starts in the colon or rectum, and it is the third most...

Vapotherm, a leading global medical technology company, is set to introduce its latest innovation, the Access365 Home Ventilation Solution, at...

Medtronic, a global leader in medical technology, recently announced a strategic shift in its approach to ventilators in response to...

Health Canada plays a crucial role in ensuring the safety and effectiveness of medical devices in Canada. One important aspect...

Health Canada plays a crucial role in ensuring the safety and effectiveness of medical devices in Canada. One important aspect...

Sysmex Corporation, a leading global healthcare company, has been making waves in the field of robotics with its innovative approach...

The INHALE-3 study, a groundbreaking clinical trial comparing the efficacy of Afrezza® with traditional insulin delivery methods, has recently released...

Starting April 1, RF Aesthetic Equipment will need a Device Certificate As of April 1, 2022, all Radio Frequency (RF)...

Genesis MedTech, a leading medical technology company, has recently announced a partnership with Silk Road Medical to improve healthcare access...

An In-Depth Analysis of Risk Assessment for Drug-Device Combination Products: A Guide by Operon Strategist

Drug-device combination products have become increasingly popular in the healthcare industry, offering a unique approach to treating various medical conditions. However, with this innovation comes the need for thorough risk assessment to ensure the safety and efficacy of these products. Operon Strategist, a leading consulting firm specializing in regulatory affairs and quality management, has recently released a comprehensive guide on risk assessment for drug-device combination products.

The guide by Operon Strategist provides a detailed analysis of the key considerations and best practices for conducting risk assessment for drug-device combination products. It covers various aspects of risk assessment, including identifying potential hazards, assessing the severity and likelihood of harm, and implementing risk mitigation strategies.

One of the key points emphasized in the guide is the importance of understanding the unique risks associated with drug-device combination products. Unlike traditional pharmaceuticals or medical devices, these products involve the interaction of both drugs and devices, which can introduce new risks that need to be carefully evaluated.

The guide also highlights the importance of involving cross-functional teams in the risk assessment process. Collaboration between regulatory affairs, quality management, engineering, and clinical teams is essential to ensure a comprehensive evaluation of all potential risks and to develop effective risk mitigation strategies.

Operon Strategist’s guide also provides practical tips for conducting risk assessments, such as using tools like Failure Mode and Effects Analysis (FMEA) to systematically identify and prioritize potential risks. The guide also emphasizes the importance of ongoing risk management throughout the product lifecycle, including post-market surveillance and monitoring.

Overall, Operon Strategist’s guide on risk assessment for drug-device combination products serves as a valuable resource for manufacturers, regulatory professionals, and other stakeholders involved in the development and commercialization of these innovative products. By following the best practices outlined in the guide, companies can ensure the safety and effectiveness of their drug-device combination products and navigate the complex regulatory landscape with confidence.