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…

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Internal audit

Internal audit – a guarantee of improving the company’s performance

Today the concept of “internal audit” is widespread in business. Many large enterprises and companies prefer to create their own internal audit services and departments, training their employees. Besides, there is a constantly growing demand on the labor market for specialists who possess relevant knowledge and have an international diploma. Tasks of the internal audit…

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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…

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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…

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General information about ISO 14001

Environmental management by obtaining ISO 14001 certification

The purpose of adopting this system is to preserve the profitability of production while reducing the level of negative impact on the atmosphere, hydrosphere, soil, and to minimize the amount of waste. Companies can confirm the adoption of and compliance with environmental management by obtaining ISO 14001 certification. Any company or business activity affects the…

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General information about ISO 14001

General information about ISO 14001

Environmental Management System standard provides not only the environmental result, but also the result of financial benefits for the organization, whose activities are built on the principles of ISO 14001. ISO 14001 ISO 14001 (Environmental Management System, EMS) is a tool that allows you to control the environmental impact of a firm, reducing it to…

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ISO 14971 RISK MANAGEMENT OF MEDICAL DEVICES

ISO 14971 – Risk management of Medical Devices

New edition of ISO 14971:2019. Medical device risk management – technical report and provisions of the standard. Change in the interpretation of risk management of medical devices. Changes to the standard from previous editions. New edition of ISO 14971:2019. ISO revised the standard under review in December 2019. This is the third edition: ISO 14971:2019…

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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…

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