Device Master Record

Device Master Record Versus Design History File Versus Device History 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

Function of Pipette Tips - Medical Consumables

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

MDSAP Audit Assessment Program

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

business in thailand bangkok

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

thailand manufacturing

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

irritation testing of a syringe

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 […]

Medical PCB (Printed Circuit Boards)

medical printed circuit board

Medical technology is continually evolving and incorporating computerized solutions which has in turn led to the evolution and incorporation of printed circuit boards, abbreviated for PCBs. Today, medical devices are becoming increasingly affordable, and user-friendly due to PCBs.  Due to the medical industry standards, medical PCBs need to demonstrate the highest standards of precision, and […]

Medical Plastics Guide

medical plastics in dental

Today, medical plastic parts are revolutionizing the healthcare industry! They are continually evolving and becoming more and more advanced in the global market. This significant impact is due to the stride development of medical polymers.  Medical polymers have transformed medical devices by replacing various materials such as glass, metals, ceramics, etc. Medical plastics demonstrate distinct […]

A Guide to Software as a Medical Device (SAMD)

SAMD software as a medical device

Today, software is an integral aspect of the medical and healthcare industry. The accelerated changes brought about by technology have created a requirement for various types of solutions which help the healthcare providers to engage with patients effectively and quickly. Such software solutions have also helped to maintain market relevance.  SAMD or SaMD, abbreviated for […]

Failure Mode and Effects Analysis (FMEA) for Medical Devices

fmea steps

Medical device manufacturers deal with various challenges to manufacture and market medical devices. These challenges range from competitive markets, stringent adherence to regulations, and maintaining high-quality product development. Among these challenges, developing an effective risk management strategy is paramount. One of the subsects of developing an effective risk management strategy is Failure Mode and Effects […]