AI in Medical Devices

AI, abbreviated for Artificial intelligence is a digital technology that has tremendous transformative potential. It has revolutionized various industries including the medical and healthcare industry.  AI technologies are continually evolving and their integration into medical devices is driving innovation to upgrade the medical devices as well. When AI medical technology is incorporated into medical devices, […]

ISO 13485 vs other ISO Standards

ISO standards enable manufacturers to focus on product quality, process and operational efficiency, consistency, and environmental responsibility. ISO 13485 is the global standard for medical device manufacturers. It ensures patient safety and consistent product quality. We have covered ISO 13485 for medical device QMS in detail in the previous article. In this article, we compare […]

ISO 13485 for Medical Device QMS

The medical device industry is highly regulated. ISO 13485 is the global standard for medical device design and development. It ensures that the medical device manufacturers meet the compliance requirements of the regulatory bodies and customers. In this article, we discuss ISO 13485, its advantages, and clauses in detail.   What is ISO 13485? ISO 13485 […]

ISO 14971 Risk Management for Medical Devices

The medical device industry is highly regulated, and risk management is a crucial aspect in almost all major markets. Today, an established risk management process is essential for developing medical devices. An effective risk management process enables medical device manufacturers to identify and manage safety issues across the life cycle of medical devices.   Risk management […]

Device Master Record

A robust quality management system is an extremely crucial aspect for maintaining the safety, compliance, and quality of a medical device. Within this system, every process, from design to delivery, follows a structured process.  Device Master Record is a type of structured documentation process that encapsulates all details such as materials, equipment, specifications, assembly instructions, […]

Medical Consumable Products: Pipette Tips

Pipette Tips are often called dispenser tips. As medical consumable products, they are part of the medical device industry, and are used on diagnostics, treatment, research, and patient care. A major segment of this industry is that of medical consumable products.  Medical consumable products are essential and disposable medical products that ensure sterility, precision, and […]

MDSAP Audit

Patient health is of paramount importance in the medical device industry, which is why it’s a highly regulated industry. Medical device manufacturers must adhere to the compliance of regulatory agencies in order to ensure product safety and quality. The MDSAP audit enhances transparency and consistency in regulatory inspections by using standardized procedures and trained auditing […]

Healthcare Equipment Manufacturing in Thailand

For over 17 years we are operating our healthcare equipment manufacturing in Thailand. Amazed by Thailand’s large medical device manufacturing community, we operate our wholly-owned production facility in Rayong, Thailand.The largest port in Thailand, called Laem Chabang Port, is just a 30-minute drive away from our facility. As Thailand has grown in favor of healthcare […]

Medical Device Manufacturing Transfer out of China

Clients are facing rising costs and import/export issues with medical device production in China. VEM Medical helps companies with an expedited medical device manufacturing transfer, usually plastic injection molding and assembly projects from China – where costs continue to rise – to Thailand with supply chains intact. Why More Companies Are Moving Medical Device Manufacturing […]

Biocompatibility Testing

Medical device design and development is an extremely complex, multi-phase process. A crucial aspect of it is biocompatibility testing to ensure that the materials used in the medical device are safe for patient use. There are various types of biocompatibility tests, and they are largely dependent upon the specifications of the medical device. In this […]