Lab Regulations & Standards for Medical Devices: Ensure Quality, Safety & Compliance

recently updated on 31st Oct 23

In previous blogs, We analyzed the positive effect of maintenance and calibration of medical equipment. Regular maintenance and calibration can improve lab operations and management, and streamlining operations results in better business. In addition, another crucial area where your lab can lose money is irregularities in laboratory regulatory compliance with respect to medical device standards and regulations.

The importance of medical device regulatory compliance in the healthcare industry is rising. There are already more than 8000 generic medical device groups, some of which include drug-containing devices. However, the vast number of medical equipment and its relation with human life emphasizes the need for strict regulatory standards for medical devices, equipment, and materials. Thereby ensuring that the equipment and service are effective and safe.

Diagnostic laboratories risk penalties, fines, legal repercussions, and loss of accreditation for medical labs if they don’t adhere to the current regulatory standards for medical devices equipment, and materials. Additionally, it may result in a loss of patient confidence and reputational harm, which would lower the lab’s profitability. Inaccurate test results can also endanger the health and safety of patients, thereby opening the door to legal action for medical negligence.

Therefore, to avoid all the unnecessary drawbacks in your lab, we will cover the regulatory requirements for medical devices and the importance of laboratory standardization. Also, we have compiled a list of essential standards with set lab rules and regulations in the USA and India for quick reference.

Significance of Lab Regulatory Compliance for Medical Labs

Any industry, including pathology, must adhere to its lab rules and regulations. Standards and Compliance regulations in a laboratory promote lab accreditation, legal adherence, ethical considerations, and patient safety. Moreover, it is a crucial component of the healthcare sector. Non-compliance can lead to fines, legal consequences, and other sanctions in addition to harming the public’s confidence.

Why is Compliance Regulations in a Laboratory Necessary?

• Lab Quality:

Lab compliance with rules guarantees that the laboratory generates precise, dependable, and consistent results for patients and doctors taking care of quality in a medical laboratory.

• Patient Safety:

By reducing the possibility of mistakes, contamination, and other unfavorable events during testing, lab regulatory compliance helps to assure patient safety.

• Legal Compliance:

Medical laboratory regulations must abide by a variety of laws, including those about lab safety, data security, patients’ health, and medical equipment. Therefore, following these laboratory laws and regulations is crucial to avoid fines, penalties, and other sanctions.

• Ethical Considerations:

Medical laboratories frequently test human samples and handle private patient information. Hence, following or Adherence to ethical principles concerning patient confidentiality and informed consent is essential to maintain the public’s trust and confidence in a standard laboratory.

• Laboratory accreditation:

To prove that laboratory laws and regulations are followed for quality requirements, many laboratories apply for accreditation from independent bodies. To clarify, laboratory accreditation can assist a lab in drawing in more clients, boosting sales, and improving its reputation.

Now that we know the reasons why laboratory regulatory compliance is essential. The next part of this article answers the question: What are the necessary medical device standards and regulations?

Medical Equipment Standards and Regulations for Medical Devices

• International Standards:

  • ISO 13485: 2016

It is a group of specifications for a Quality Management System (QMS) in the medical device sector. These quality management standards include manufacturing, storage, distribution, installation, servicing, and all other phases of the medical device’s life cycle.

• • ISO 14971: 2019

Describes the procedure for managing the risk associated with in vitro medical devices, software as a medical device (SaMD), and medical devices. A standard laboratory covers the identification of hazards, assessing the risks attached to them, and putting risk controls in place by medical device manufacturers. The standard’s definition of risk management states that it should be a continuous process that spans all phases of the lifecycle of a medical device.

• • IEC 62304: 2015

The laboratory standards and guidelines provide a framework for the processes, positions, and duties involved in the software lifecycle of medical devices. This standard specifies the lifespan for software in use as a medical device, a component of a medical device, or in the manufacturing of a medical device (SaMD).

• Regulations in the USA

  • FDA 21 CFR Parts 11

21 CFR Part 11 covers the FDA’s regulations for electronically preserved records. Electronic records can replace manual records. The electronic records of the manufacturer are reliable because they comply with this act. In addition to manual signatures, this legislation also governs electronic signatures. However, electronic records transmitted electronically are exempt from this law.

• • FDA 21 CFR Parts 820

The FDA’s Quality System Regulations for medical device production and process control is in 21 CFR Part 820. By establishing regular calibration procedures, these medical laboratory regulations enable manufacturers to offer reliable inspection and test equipment results. Moreover, under this law, manufacturers must handle all medical devices carefully to preserve their accuracy.

• • Quality System Regulation (QSR)

The FDA’s Quality System Regulation (QSR) is a quality management standard for medical device manufacturers. Only finished, usable medical equipment falls under the QSR. Moreover, the QSR offers adaptable regulatory standards for medical devices in all, and not just one specific type. According to QSR, the manufacturer must create and implement laboratory quality management policies per the QSR rules.

• Regulations in India

There are three regulatory bodies in India:

1. 1. Central Drugs Standard Control Organization (CDSCO) and
   2. Indian Council of Medical Research
   3. The National Accreditation Board for Testing and Calibration Laboratories (NABL)

The Regulations Act of 2020 explains medical device regulatory compliance. The Ministry of Health and Family Welfare’s Central Drugs Standard Control Organization, which includes the Drug Controller General of India (DCGI), regulates medical devices and IVDs (CDSCO).

The Drugs and Cosmetics Act 1940 (“DCA”) standard and security of medical devices in India. The DCA only applies to “notified medical devices,” which the government routinely classifies as “drugs.” The Medical Device Standards and Regulations, 2017 (“MDR”), were created per the DCA.

The National Accreditation Board for Testing and Calibration Laboratories (NABL), an independent organization to accredit the testing and calibration of clinical laboratories throughout the country, is managed by the Department of Science & Technology, Government of India.

Furthermore, managing high quality in the laboratory requires careful planning and efficient resource and laboratory quality management. Thus, it is crucial to balance the expenditures associated with new equipment investment and its upkeep. A clear field policy, technical direction, and valuable instruments for maintaining the functional parameters are required to support medical equipment’s proper use and maintenance. Therefore, there is a standard calibration laboratory set up under NABL.

Lab Regulations with set Regulatory Standards for Medical Devices, equipment, and materials are essential in the medical Industry. These laboratory regulations are crucial, as explained below, for patient care as well as the reputation of a lab. A reputed lab is always a preference for patients and medical professionals.

Importance of Regulatory Standards for Medical Devices, Equipment and Materials

The main goals of setting up medical equipment standards and regulations are to prevent access to harmful items and to provide patients with high-quality, safe, and effective medical equipment. Also, a lab that follows all the laboratory laws and regulations translates to reliability for the patients.

International regulatory requirements for medical devices are in place to ensure systems, services, or products’ safety, quality, and efficiency in a laboratory. A lab that follows international laboratory standards and guidelines for equipment manufacturing also assures lab quality. Assuring safety and quality in a medical laboratory is therefore pivotal in the healthcare business.

A diagnostic lab with proper management, laboratory laws and regulations, and software services can optimize solutions. Many features of CrelioHealth are capable of automating and executing tasks without human interference. As a result, the automation reduces errors and increases the profitability and reliability of the lab. So, to gain more insight on the maintenance of medical equipment and Calibration of medical equipment read our blogs in the series.