The United States (US) Food and Drug Administration (FDA) mandates that medical device manufacturers must comply with quality management systems to guarantee consistency in their products and comply with any specifications or requirements.
In the 1960s and 1970s, the US Congress responded to the public’s desire for more oversight over medical devices by eventually passing the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. To increase product safety, the FDA began regulating medical device manufacturing in 1978. Then, in 1982, the organizational units at the FDA that regulated medical devices and radiation-emitting products merged to form the Center for Devices and Radiological Health (CDRH).
The US FDA has repeatedly delayed aligning its Quality System Regulation (known to many as QSR and found at 21 CFR 820) with ISO 13485 but has indicated it plans to issue proposed regulations in 2021. Since the US and international standards vary, it can make record-keeping and the cost of compliance expensive. Still, the adoption of the international standard could help reduce costs and make it easier for US companies to comply internationally.
The US FDA recently made a formal announcement that they will be replacing parts of the existing Quality System Regulation (QSR 21 CFR 820) with the international standard ISO 13485:2016. Currently, this transition is still in the making and is in the ruling stage.
The Association for the Advancement of Medical Instrumentation (AAMI) has published a technical information report (TIR), AAMI TIR102:2019, that compares the requirements of 21 CFR 820 with ANSI/AAMI/ISO 13485:2016. This report would be valuable for your organization to review to ensure internal process and leadership alignment.
Companies can also certify in many of the ISO standards for medical devices to increase credibility and marketability. This article will highlight the various common ISO medical device standards currently available.
While complying with regulations and standards may seem tedious, these standards offer better efficiency, increased safety, and better quality, which ultimately leads to higher revenue for your medical device manufacturing business.
Why Standards for Medical Devices
Medical device standards regulate and maintain product conformity during the design and manufacturing of medical devices. These standards are utilized both domestically and internationally to ensure quality and consistency between different products.
These standards govern the design and manufacturing of a wide range of products that treat and diagnose various illnesses and injuries. The standards ensure that medical devices have the highest safety and quality that doctors can rely on to treat medical problems and diseases.
The Most Common ISO Medical Device Standards
The US FDA does acknowledge some ISO standards. Please check out this link to see if a specific standard is recognized:
Recognized Consensus Standards
To maintain the highest safety levels, you’ll want to incorporate these standards into your medical device manufacturing:
ISO 9001:2015: Quality Management Systems – Requirements
The ISO 9001 manufacturing standard isn’t industry-specific and requires management to monitor the quality control process. Based on the Annex SL directive, the ISO 9001 utilizes a popular structure and lexicon to integrate and comply with other standards. It regulates the quality management process, benefiting the company by (1) Reducing costs, (2) Driving responsible growth, (3) Simplifying compliance to regulations, and (4) Creating transparency for accountability.
Related article: What Is The Difference Between Quality Control and Quality Assurance?
ISO 13485:2016: Medical Devices – Quality Management Systems – Requirements for regulatory purposes
Like ISO 9001, ISO 13485 is a quality management standard that manages quality control specifically for manufacturing medical devices. As mentioned above, a global standard, ISO 13485, isn’t mandatory in the United States but is required in some countries.
Based on the ISO 9001 framework, the ISO 13485 expands the framework to incorporate medical device regulation requirements, better risk management, and increased supply chain regulatory requirements. ISO 13485 evolved out of the general quality management system standard ISO 9001 and is specific to the medical device industry.
The ISO 13485 also complies with international markets, which is necessary for global expansion. By designing medical device manufacturing to be compliant with ISO 13485, your business will (1) Increase efficiency, (2) Reduce operation risks, (3) Expand quickly to international markets, (4) Increase quality control, and (5) Provide traceability.
Not sure where your medical device manufacturing business is lacking? Learn more about Global Strategic Solutions, LLC consulting, and GAP assessment services.
ISO 14971:2019: Medical devices — Application of risk management to medical devices and its guidance ISO/TR 24971:2020
Risk management is one of the more complex aspects of regulatory compliance within the medical device sector. Risk comes in so many ways along with perceptions of severity and the probability of harms actually occurring. The intent of ISO 14971 is to define a standard process for identifying risks at all stages in a device’s life cycle, from product concept, design, purchasing, production, and then post-market use. The goal is to analyze, evaluate, control, and monitor risks continuously during each life-cycle stage throughout the medical device’s lifetime.
ISO 14155:2020: Clinical investigation of medical devices for human subjects — Good clinical practice
Conducting a clinical investigation with medical devices according to the ISO 14155:2020 standard provides a high level of protection for human research subjects and allows companies to perform international device trials that generate clinical data with high integrity that are accepted by regulatory agencies worldwide.
ISO 14001:2015 Environmental Management Systems
ISO 14001 is an internationally agreed standard that sets out the requirements for an environmental management system. It helps organizations improve their environmental performance through more efficient use of resources and reduction of waste, gaining a competitive advantage and the trust of stakeholders. It ensures your manufacturing processes will (1) Conserver energy, (2) Reduce waste, and (3) Leave a smaller carbon footprint.
Based on the Annex SL framework, the ISO 14001 has certified quality management that is relatively easy to implement and offers a high-quality standard for safety, health, and environmentally conscious medical devices.
ISO 50001:2011 Energy Management Systems
ISO 50001:2011 specifies requirements for an organization to establish, implement, maintain and improve an energy management system, which enables that organization to take a systematic approach in order to achieve continual improvement of energy performance, including energy efficiency, energy use, and consumption. The standard is based upon the Plan-Do-Check-Act management system, which is familiar to many manufacturing plants that have implemented other ISO standards. It works well with ISO 14001 as manufacturers (1) Reduce operating expenses, (2) Increase energy efficiency, and (3) Comply with strict regulations.
ISO 10993 Family of Standards: Biological Evaluation of Medical Devices
Part 23 of this standard was harmonized in July 2021 to support (EU) 2017/745 [EU MDR]. The ISO 10993 is a series of standards for evaluating the biocompatibility of medical devices. These documents were preceded by the Tripartite agreement and are a part of the international harmonization of the safe use evaluation of medical devices. Medical devices that come into contact with the human body are required by regulatory authorities to be tested on possible interactions and potential unwanted side effects. Therefore, medical devices are assigned to different categories depending on the kind of contact and the contact time to the human body.
ISO 45001/ OHSAS 18001: Occupational Health and Safety Management Systems
If your business is accredited to OHSAS 18001, you now have until 30th September 2021 to make the OHSAS 18001 to ISO 45001 transition. ISO 45001/ OHSAS 18001 is a set of requirements that regulate occupational safety and health management within the medical device industry. Medical device manufacturing often utilizes advanced technology that can come with occupational risks.
The ISO 45001/ OHSAS 18001 standards protect your production team by establishing and adhering to strict safety requirements, ultimately increasing productivity and reducing risk, accidents, and liability issues.
ISO/IEC 27001:2013 Information technology — Security techniques — Information security management systems — Requirements
Protecting your organization’s information is critical for the successful management and smooth operation of your organization. Achieving ISO 27001 will aid your organization in managing and protecting your valuable data and information assets.
ISO 27001 helps safeguard your business from cybersecurity risks. In an era of rampant and constant cyber breaches, it is imperative to protect your systems and products from cyber threats. Based on international best practices for fortifying your business from cyberattacks, the ISO 27001 is a critical manufacturing standard that allows your business to discover, assess, and prevent cybersecurity breaches.
The basic goal of ISO 27001 is to protect three aspects of information:
- Confidentiality: only authorized persons have the right to access information.
- Integrity: only authorized persons can change the information.
- Availability: the information must be accessible to authorized persons whenever it is needed.
ISO 20417:2021: Medical Devices — Information to be supplied by the Manufacturer
ISO 20417 summarizes the requirements of various relevant regulations in a clear and comprehensible manner. It clarifies some requirements of the MDR/IVDR that were not very clear and gives practical guidance on how to comply with them. It is on the list of standards to be harmonized under the EU Medical Device Regulations.
Current EU MDR and IVDR Harmonized Standards
We will see a rapid release of standards being harmonized with the new medical device regulations in Europe. Below are five EU MDR and four EU IVDR standards that have been harmonized.
ISO Medical Device Standards Compliance is an Excellent Way to Increase Credibility
By implementing and certifying to these ISO medical device standards, you’ll be able to increase your business’s credibility and boost efficiency, profits, transparency, quality, and sustainability. You’ll want to research each of these international standards carefully to determine which standards are best for your business.
Global Strategic Solutions offers medical device regulation (MDR) gap assessment and remediation to evaluate your business’s quality management, safety, and clinical performance. Our team of experienced consultants knows what it takes to get medical devices approved and ready for market.
Not sure if your medical device is compliant with ISO standards? Contact Global Strategic Solutions for quality management consulting.
David R Rutledge, Pharm.D., FCCP, FAHA, President & CEO, Global Strategic Solutions, LLC, Silicon Valley in California.
+1 (630) 846-0350 cell