• As the world's technology continues to evolve and improve, so too does the technology used in the medical sphere.

    • The future of Medical Devices


      The future of medical devices and medical technology is bright, with spectacular innovations being created every day. Technology within the medical field has an enormous impact on all processes and procedures, and improvements will only further grow and improve.

      As technology continues to drive the pace of change and healthcare, it will allow medical experts to change the way we change, and move into spaces where the concept of self-improvements is inherent in each piece of technology.

      Below are four extraordinary medical device advancements with long-lasting and positive results.

      • Robotics surgeries


        After billions of dollars of investment, robotic surgeries, or robotic assisted surgeries are here to usher in a new age of hyper-precise medical treatments. These surgeries allow for more precision, flexibility, and control than traditional or conventional techniques. These sort of surgeries are normally minimally invasive, making the recovery process much easier for patients.

        As well as a quick recovery time, robotic surgeries also generally boast fewer complications, less pain and blood loss, and smaller/less noticeable scars.

        Standards are still developing in this area, as the field continues to grow. Currently however the IEC 80601-2-77: 2019 Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential requirements of robotically assisted surgical equipment Standard is used. 


        3D printing


        3D printing is a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete. Additive manufacturing, or 3D printing, has existed for decades, however it is only in the past several years that the technology has been refined enough for use in the medical field.

        3D printing offers limitless possibilities. This technology offers products that are entirely bespoke for the user, allowing maximum comfort and mobility that was previously unattainable. 3D prints can be any size or shape allowing for endless possibilities. 3D body parts, casts, stents and more are being used every day to improve lives. 

        ISO ASTM 52910:2018 Additive manufacturing - Design provides requirements, guidelines and recommendations for using additive manufacturing in product design.


        TAVR Stents


        Transcatheter aortic valve replacement (or TAVR) is a minimally invasive procedure where a new valve is inserted without removing the old, damaged valve in the heart.

        Somewhat similar to placing a stent in an artery, the TAVR approach delivers a fully collapsible replacement valve to the valve site through a catheter. Once the new valve is expanded, it pushes the old valve leaflets out of the way and the tissue in the replacement valve takes over the job of regulating blood flow. The medical device used in this procedure, a stent, has saved countless lives.

        Given the importance of this small medical device, there is no room for error in their manufacturing. The ISO 5840 family of Standards pertains to cardiovascular implants, from the design and manufacture all the way to transcatheter implantation techniques and is crucial in the safety of this medical device. 


        IUD


        Intrauterine devices are long acting reversible contraceptives (LARC). The device is a small T-shaped plastic device that is placed in the uterus to prevent pregnancy or regulate menstruation. These devices have existed for over 50 years, and now exist in two forms: copper and hormonal.

        These two types both sit in the uterus and are designed for long term use (between 3 to 10 years depending on the type and brand used). Improper or ineffective contraception can have very serious consequences for the user, both in terms of bodily health/hormonal changes as well as unplanned pregnancy.

        These devices must be made the strictest of standards and regulations to ensure they perform their role perfectly. Standards used in IUD assurance include ISO 11249 Copper-bearing Intrauterine Contraceptive Devices - Guidance On The Design, Execution, Analysis And Interpretation Of Clinical Studies and ISO 7439 Copper-bearing contraceptive intrauterine devices - Requirements and tests, which specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments.

        • Understanding ISO 14971:2019

          The updated Standard for the application of risk management to medical devices

        • 8 benefits of Standards

          Compliance with Standards has a range of benefits for organizations, consumers, governments and the community at large.

        • Medical Devices Standards Management

          Rigid regulatory obligations leave no room for error in the Medical Devices industry

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