An Overview of Medical Device Standards
Companies that manufacture and distribute medical devices must follow specific standards set by international medical device regulators. Compliance with these regulatory requirements ensures manufacturers are producing high-quality medical devices in a safe working environment.
Importance of Medical Device Standards
With the rise of healthcare technology, the medical device industry has become increasingly competitive, gaining the attention of international regulatory authorities. When markets become competitive, manufacturing companies are forced to prioritize the quality of their products while finding ways to optimize manufacturing processes. To ensure the safety and quality of the produced medical devices, international medical device regulators have created standards for the manufacturing process.
These standards are intended to promote safe manufacturing practices and encourage global trade and collaboration between companies. When medical devices are standardized, they can be used by a larger population of customers, which results in a more competitive market. Additionally, these standards make it easier for regulatory authorities to test and measure the quality of medical devices, ensuring the customer is receiving a high-quality device that will support their health.
The Role of Regulatory Bodies in Developing Standards
The two most commonly referred to regulatory bodies for medical devices are the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).
The ISO’s primary goal is to create industry standards that encourage companies across the world to trade and cooperate, fostering innovation and sustainability. The ISO has created multiple standards in the healthcare industry, primarily focused on medical devices and information technology. These standards outline basic safety and performance requirements for medical device manufacturers to follow throughout the design, production, and post-market process.
The IEC creates global standards to support the infrastructure for international trade and collaboration between companies producing, distributing, and utilizing electronic goods. The IEC has developed standards for multiple industries and technologies, including healthcare technology and medical device development. The IEC’s standards on medical devices can be used to develop a manufacturing company’s risk management policies surrounding product testing and quality certifications.
Key International Medical Device Standards
While there are a large number of international standards created for the healthcare industry, there are a handful of essential standards that all medical device manufacturers should follow.
ISO 13485: Medical Devices Quality Management Systems
ISO 13485 outlines the requirements to ensure an organization’s medical devices are up to the customer and regulatory requirements for quality and safety. This standard serves as the framework for a consistent medical device product lifecycle, including design, development, production, and delivery. ISO 13485 helps manufacturers meet intensive regulatory requirements and ensure their manufacturing processs meets the industry’s best standards for safety and quality.
ISO 14971: Application of Risk Management to Medical Devices
ISO 14971 defines specific terminology, principles, and processes for a company’s risk management of medical devices. This standard provides a framework for companies to:
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Identify medical device hazards and risks
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Estimate the risks associated with medical devices
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Evaluate the associated risks
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Determine how to control the associated risks
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Monitor the effectiveness and success of the controls during the product lifecycle
The risk management process outlined in this standard starts at the initial conception of the medical device and ends at the decommissioning and disposal of the device. The standard covers all risk types, include biocompatiblity, data security, systems security, moving parts, radiation, usability, and electricity.
IEC 60601 Series: Medical Electrical Equipment Standards
The IEC 60601 series covers the basic safety and performance requirements of medical electrical equipment and systems used in a home healthcare setting. This standard is applied to all equipment and systems used in a home setting, both operated by trained healthcare professionals or laymen operators. A home healthcare environment can be defined as a place where a patient lives or a setting where patients are present, but healthcare professionals are not.
ISO 15189: Medical Laboratories Standard
ISO 15189 focuses on the quality and competence of medical laboratories, outlining the specific requirements they must comply with. This standard primarily applies to how laboratories develop a management system and how their competence can be assessed. This standard is also used by laboratory users to confirm or recognize the competence level of a medical laboratory to regulatory entities.
Aligning Your Medical Devices with International Standards
While following international standards is crucial to a manufacturing company’s success, it can be difficult to ensure compliance and create the necessary reports and documentation. With a custom software solution, manufacturing companies can monitor their risk management workflows with ease.
The Importance of Complying with Medical Device Standards
There are a couple of reasons why it’s in a manufacturing company’s best interest to comply with medical device regulatory systems. International standards increase the likelihood of compatibility among manufacturers, medical device companies, and healthcare organizations. This will encourage competition in the market, which ultimately improves the quality of the medical devices.
Compliance with these standards is also critical in healthcare manufacturing, as medical devices can have a direct impact on someone’s health and quality of life. For example, ISO 11607 is a standard for packaging medical devices so they are sterilized. The sterile processing system is how healthcare providers can ensure the patient is being treated with sterile devices, reducing the risk of infection.
Steps for Ensuring Compliance of Your Medical Devices to International Standards
Manufacturing companies can use software systems to track and manage regulatory compliance through quality management, document control, and reporting capabilities. When manufacturers can manage the evaluation of medical devices from a software system, they gain more control over the manufacturing process and can accurately report their compliance with medical device regulations.
These software systems could be off-the-shelf or custom-built for a manufacturing company’s specific requirements and operational workflows. To determine which is the best solution for a company, they must consider data security, manufacturing processes, and how it would integrate with current systems.
Setting Up a Quality Management System for Medical Devices
Quality management systems (QMS) are used to manage and report the quality of materials throughout the manufacturing process, allowing manufacturers to access historical and real-time data. QMS software can also track data on the manufacturing process itself, including production times, employees on shift, and temperature controls. With custom QMS software, medical device manufacturers can ensure they are meeting industry standards, instilling trust with healthcare providers.
Work With Geneca Today
Geneca has over 25 years of experience creating and maintaining high-quality, reliable custom software solutions. Our partners choose us because we:
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Understand software and business, including industry processes and regulations
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Use cutting-edge technology paired with trusted, evergreen tools
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Communicate changes, progress, and expectations through every step of the development process
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Honor your budget and timeline from the start
If you’re ready to ensure your medical devices meet international compliance standards, contact us today!