Medical devices made to a Standard
Organisations within the medical devices industry have a responsibility to meet safety and quality requirements, to ensure safe use for the end consumer.
The industry is demanding, where innovation is essential to keep moving forward with medical services, procedures and care. While striving to create better, safer and more reliable products and services, all current and future projects must work towards meeting the regulatory requirements.
Standards help guide organisations through all business functions, including product development, quality assurance, management strategies and even cost efficiencies.
It's important to remember that compliance within the medical devices industry means much more than just ticking boxes. It can mean crucial differences of the performance of a product or service, directly affecting the end consumer. Being able to rely on safe, standardised, and predictable devices that meet the required Standards can shorten development and production times, allowing for swift solutions in a variety of circumstances.
Essential Safety and Quality Standards for Medical Devices
Medical device safety and quality Standards are fundamental for ensuring that devices meet rigorous requirements for reliability and patient safety. These Standards encompass various elements, including electrical safety, alarm system protocols, and battery Standards, providing a robust framework to minimise risks and improve device performance. Compliance with these Standards helps manufacturers meet global regulations, supporting the safe use of medical devices across different healthcare settings and instilling confidence in healthcare providers and patients alike. Popular Standards include:
- ISO 14971:2019 - Medical devices — Application of risk management to medical devices
- ISO 13485:2016 - Medical devices Quality management systems Requirements for regulatory purposes
- ISO 10993-1:2018 - Biological evaluation of medical devices Part 1
- ISO 18562-1:2024 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1
Medical Device Design and Manufacturing Standards
Standards for the design and manufacturing of medical devices guide manufacturers in creating products that are both safe and functional. Design Standards address requirements for usability, safety, and compatibility, while manufacturing Standards ensure consistent quality during production. These Standards also incorporate best practices in engineering, helping to streamline the production process while maintaining high levels of safety and compliance. By adhering to these Standards, manufacturers can produce devices that meet international expectations and are fit for use in diverse medical environments. Popular Standards include:
- ISO 11607-1:2019 - Packaging for terminally sterilized medical devices
- ISO 14160:2020 - Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices
- ANSI/AAMI ST90:2017(R2024) - Processing of health care products—Quality management systems for processing in health care facilities
- ISO 14708-5:2020 - Implants for surgery — Active implantable medical devices — Part 5
Medical Device Software, Cybersecurity, and Validation Standards
As medical devices integrate more advanced software, cybersecurity and software validation have become crucial elements of industry Standards. Software Standards define protocols for development and testing, ensuring reliability and accuracy in device operation. Cybersecurity Standards protect devices from unauthorised access, securing sensitive patient data and maintaining device integrity. Validation Standards confirm that device software performs as intended, providing a secure and efficient framework for use in healthcare settings and addressing the critical importance of data protection. Popular Standards include:
- ISO/IEEE 11073-10101:2020 - Health informatics — Device interoperability — Part 10101
- ISO/IEEE 11073-10700:2024 - Health informatics — Device interoperability — Part 10700
- NEMA LC P1:2019 - Medical Imaging Device Lifecycles
- NEMA/MITA CSP 1:2016 - Cybersecurity for Medical Imaging
Medical Device Packaging, Labelling, and Compliance Standards
Packaging, labelling, and compliance Standards ensure that medical devices are clearly identified, safely stored, and accessible for healthcare professionals and patients. Labelling Standards provide essential information, such as usage guidelines, safety warnings, and regulatory details, while packaging Standards protect devices during transport and storage. Compliance Standards ensure that devices meet all applicable national and international regulations, supporting manufacturers in delivering devices that adhere to high safety and usability criteria. Together, these Standards help streamline the distribution and use of medical devices across healthcare markets. Popular Standards include:
- ISO 3826-2:2008 - Plastics collapsible containers for human blood and blood components — Part 2
- ISO/TS 82304-2:2021- Health software — Part 2: Health and wellness apps — Quality and reliability
- ASTM D 6603 : 2019 - Standard Specification for Labeling of UV-Protective Textiles
- ISO 15223-2:2010 - Medical devices — Symbols to be used with medical device labels
Testing, Risk Management, and Reliability Standards for Medical Devices
Reliability and risk management Standards for medical devices cover essential testing processes that ensure product durability, stability, and consistent performance. Testing Standards define protocols for verifying device functions and resilience, while risk management Standards guide the identification and mitigation of potential hazards. By implementing these Standards, manufacturers can proactively address device risks and enhance reliability, reducing the chance of failures in clinical settings and promoting patient safety. This rigorous approach to testing and risk management supports the production of dependable medical devices that maintain high Standards of quality and safety throughout their lifecycle. Popular Standards include:
- ISO 7405:2018 - Dentistry Evaluation of biocompatibility of medical devices used in dentistry
- ISO 10993-17:2023 - Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
- AS ISO 20776.2:2024 - Clinical laboratory testing and in vitro diagnostic test systems
- ISO 21649:2023 - Needle-free injection systems for medical use — Requirements and test methods
Related Blogs
Health Care Technology
Search ICS Category Code 11
Ultimately, health care technology focuses on improving services, products and treatments. Standards assist by setting industry best practice approaches, test methods, framework for management systems & strategies.
The Power of Predictability in Medical Devices
Predictability in challenging times within the MedDev industry
Challenging times arise from unpredictable circumstances. Predictability usually translates into low risk situations, whereas unpredictability usually translates into varying types of risk (including residual or inherent risks).
Understanding ISO 14971:2019
The medical device risk management Standard
The third edition of ISO 14971:2019 was published in December 2019 and provides a thorough process for manufacturers within the medical device industry to assess, monitor, and control risks in the creation and use of a medical device.
Control the Spread of Infection
Three Important standards in healthcare and medical industries
In hazardous conditions, such as the potential for the spread of infection, the use of specific Standards can assist in guiding businesses and individuals in best practices for controlling the spread.
Understanding the delay of MDR2020
The Medical Devices Regulation 2020
The transition started in May 2017, and was due to finish in May 2020. There has been an enormous global effort across the industry to meet the new regulations by it's May 2020 deadline, when all previous MDD will become void.
Medical Devices Regulatory Obligations
Staying compliant in the medical device industry
Continuing to meet your regulatory obligations means ensuring that your organisation is always using up-to-date and current Standards. i2i can help those in the MedDev space to stay compliant past the short-term focus on the EU MDR 2021 deadline.
Quality Management Systems in Medical Devices
ISO 13485 specifies requirements for a comprehensive QMS
ISO 13485 is the internationally recognised Standard to assist those specifically in the Medical Devices industry to create a quality management system (QMS) that helps ensure safe and high-quality products are delivered.
Medical Device Labelling
Medical device manufacturers obligations
Medical device labelling requirements are essential to meet regulatory and compliance obligations and assist with the safe use of the device.
Medical Industry and Device Standards
Medical device quality management systems
Medical devices are created and used to provide care and services to those who require it. Their role is to assist with the health, wellbeing and safety of everyone involved. Standards are essential to ensure products and services meet benchmarks.
Securing Healthcare Records and Privacy
A need for standardised patient information security
As the world of technology pushes the boundaries and possibilities within healthcare, a standardised approach to handling, storing and accessing medical data needs to move at the same pace.
Medical Devices Quality Requirements
MDR impact on Quality Management Systems
With the medical device industry working hard to update their processes and products to comply with the new MDR regulations, a key focus within the industry needs to be keeping up with quality requirements during this transition.
Guiding safe and Sterile Environments in Healthcare
Standards providing guidance in healthcare
As we are all still getting used to living in a world with COVID-19, sterilising techniques are under the spotlight. To help ensure the safety of healthcare workers, patients and broader community, we all need to do our part to stop the spread.
Is EU MDR 2020 the Brexit of the Med Dev industry?
EU MDR 2020 Transition
With the looming deadlines and constant headlines talking about the coming changes, the parallels between EU MDR 2020 and Brexit are uncanny.
MedDev Product Design to Product Development
Managing production design to development risks in the industry
As regulations are enforcing stricter standards for safety and quality, there is a critical need to have a comprehensive Standards Management system in place to provide access to Standards and technical documents at each stage of the process.
Standards Management
Adopt a powerful, user-friendly Standards Management solution
i2i is a cloud-based, configurable and secure platform for the storage, retrieval and distribution of your Standards, policies and technical documentation