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.
Popular medical device Standards
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.
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