Internal audit of a medical organization

Internal audit of a medical organization

Approaches to the organization of the internal audit function in a medical organization can be classical, focused on the International Framework for the Professional Practice of Internal Auditing, developed by the Institute of Internal Auditors. This organization of control activity is based on the concept of Three Lines of Defense. Control environment of medical organization…

Safety requirements for medical devices

Safety requirements for medical devices

Safety requirements for medical devices have been shaped throughout the history of medical devices, gradually becoming more complex and complemented by new items. Medical device manufacturing is a fast-growing industry that offers increasingly sophisticated and innovative solutions based on unique technologies. As devices and equipment become more technologically sophisticated, the evaluation criteria that clinics and…

Australian Register Therapeutic Goods for Medical Devices

Australian Register Therapeutic Goods for Medical Devices

Therapeutic commodities are health-related items. Medical implants may be utilized to treat or prevent disease, change the body’s fluid balance, avoid or detect pregnancies, and replace or remodel parts and structures of the body. Healthcare equipment like stitches and band-aids are examples of therapeutic goods. Additional examples include antiseptics and blood products and supplementary and…

ISO 13485 Medical Devices

ISO 13485 Medical Devices

Safety in quality is very important in the medical devices space. Regulatory requirements are becoming increasingly stringent throughout the product lifecycle, with a focus being placed on competence, requirements, and design validation activities. In addition, there is a larger expectation for organizations to not only demonstrate product compliance, but adherence to their own quality management…