Role of Standards in the Assessment of Medical Devices

Medical devices play a pivotal role in modern healthcare, contributing to improved patient outcomes and enhanced quality of life. The integration of technology into medical devices has been a driving force behind the progress of modern healthcare. Every day thousands different kinds of medical devices are estimated to be used in health care facilities and elsewhere all over the world. The global medical device market is worth over US 150 billion, and the market is expected to grow steadily by 4% to 5% annually by implying that this technological revolution in health will continue in the foreseeable future.The assessment of medical devices based on standards plays a critical role not only in ensuring product safety, quality, and performance but also support regulatory compliance, innovation, and global market access. Through their role in harmonizing regulations, guiding device design, and ensuring ongoing safety through post-market surveillance, standards safeguard both patients and healthcare providers while fostering an environment for technological advancement in the medical device industry.

Role of Standards in the Assessment of Medical Devices Keywords:

Standards , Assessment , medical devices , safety , performance