Nanjing Elephant-Med instrument Co. , Ltd.
MOBILE：
ADDR：86 Shuanggao Road, Economic Development Zone, Gaochun District, Nanjing City
WEBSITE：http://www.elephant-med.com/
Medical devices must adhere to strict general control and procedural guidelines. To ensure the safety and effectiveness of medical devices, standards must be developed and applied. Several regulatory bodies and standards organizations collaborate to establish recognized standards for medical equipment. The development of performance characteristics, characterization and testing methods, manufacturing practices, product standards, scientific protocols, compliance standards, ingredient specifications, labeling, and other technical or policy standards constitutes standardization activities.
Medical devices are used to diagnose and treat diseases, improve health, and enhance patients' quality of life. Implants and imaging equipment are among the products utilized in healthcare. Each year, leading companies in the medical device industry generate billions of dollars in revenue. Given that medical devices are essential tools in healthcare and directly impact public health and quality of life, their safety is imperative. Companies must adhere to relevant medical device manufacturing standards to achieve optimal outcomes for all parties and prevent product recalls. These standards ensure consistent high quality throughout the manufacturing or design process, thereby effectively serving patients and healthcare professionals.
Major International Medical Device Standards
Compliance with international standards provides opportunities for medical device manufacturers to enter global markets. The name of a standard is typically represented by a combination of several integers and numbers. The letter at the beginning of the standard is the abbreviation of the issuing body, the number before the colon is the standard number assigned by the standard-setting body, and the number after the colon is the year of publication.
Two associations jointly issue global standards: the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).
ISO standard
In the medical device industry, ISO 13485:2016 is the primary standard for quality management systems (QMS), designed to ensure medical devices are properly designed, manufactured, delivered, and disposed of.
ISO 9001:2015 is the quality management standard used by medical device manufacturers to ensure product quality.
ISO 27799:2016 establishes requirements for medical device manufacturers regarding the confidentiality and security of patients' personal health information.
Under ISO 14001:2015, medical device companies must establish environmental management systems to reduce waste and conserve energy.
Medical device manufacturers implementing ISO 50001:2018 can establish energy management systems enabling them to continuously improve energy efficiency.
ISO 14971:2019 provides risk management guidance for medical devices, software intended as medical devices, and in vitro diagnostic medical devices.
As part of ISO 45001:2018, a health and safety management system applicable to the medical device industry is defined to reduce occupational accidents and related liability issues.
ISO 15223-1:2016 specifies symbols for use on medical device labels and accompanying documents, as well as on packaging containing medical devices.
As part of ISO 16142-2:2017, it lists and defines fundamental principles for the safety and performance of medical devices and identifies criteria and guidelines for assessing whether medical devices comply with these principles.
The ISO 18113-1 standard provides general principles and basic requirements for information needed by manufacturers of in vitro diagnostic medical devices.
IEC Standard
According to IEC 62304:2006, the life cycle of medical device software is specified.
IEC 62366-1:2015 defines medical device usability as the process of analyzing, specifying, developing, and evaluating medical devices. It further describes how to assess and mitigate risks during the correct use of the device.
IEC 82304-1:2016 provides manufacturers with guidance on the safety and security of health software products without dedicated hardware.
As a medical device manufacturer, ISO compliance helps demonstrate the high quality and safety of its products, as well as the manufacturer's commitment to environmental and consumer interests.
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