An introduction to standards for medtech companies

Bethaney Lentz
January 3, 2024
An introduction to standards for medtech companies

A standard is a published document that is established by consensus and is approved by a recognized body (ISO, IEEE, UL, etc.). It outlines requirements, specifications, guidelines, or characteristics that are used in a repeated way to ensure that materials, products, processes, and services are developed for a specific purpose. Think of it as a formula for an agreed upon way of doing something that establishes the best way of performing a function. It could be developing a product, managing a process, or even supplying materials to a manufacturer.

Why are standards important?

Standards enable technology to work seamlessly across industries and markets and help to build consumer trust that products and services are designed to work together in an efficient way. They form the fundamental building blocks for product development by establishing consistent requirements that can be universally applied, practiced, and understood. For example:

To ensure standards stay relevant and are aligned with technology changes, many standards organizations require that their standards be reviewed periodically and updated as necessary.

Is an industry standard the same as a regulation?

No, but there is a very close relationship between the two. Simply put, a standard is a guideline whereas a regulation includes laws. Industry standards are used voluntarily (although strongly encouraged) while regulations are not voluntary because they are a requirement from a government agency or similar authority, i.e. ISO 13485 is a standard and building codes are regulations.

  • Standards are technical documents, driven by consensus that are crafted by experts.
  • Regulations are sometimes based on standards, created by a variety of individuals and entities, while overseen by federal, state, and/or municipal authorities.

It's important to note that while standards aren't mandated by law, many regulatory authorities recognize standards and recommend adherence to them in order to promote safety and quality.

What kind of standards are medtech manufacturers responsible for tracking?

The medical device industry has the responsibility for the design and manufacturing of a wide range of products used to diagnose and treat illnesses to improve health in patients. Medical device standards help ensure that a manufacturing or design process can consistently produce the quality required to serve patients and healthcare professionals around the world.

Some of the more common standards used by the medtech industry include, but are certainly not limited to:

ISO 9001 – A general standard (not industry specific) for quality management and implementing a rigorous quality system. For medtech specifically, it helps with the management of the quality control process by helping to keep costs low, improve accountability and simplify regulatory compliance.

ISO 13485 – This standard is designed for medtech specifically and expands on the framework set up by ISO 9001. Compliance with this standard helps with quality control, process validation, and risk management, often referred to as the risk management standard.

ISO 14971 – This standard specifies terminology, principles, and a process for the risk management of medical devices, including software and in vitro. This helps to identify hazards that may be associated with devices and to minimize those risks.

IEC 60601-1 – Medical Electrical Equipment, general requirements for basic safety and essential performance of equipment.

ISO 10993 – Biological evaluation of medical devices that includes biocompatibility testing of materials used to design product parts that would come into contact with a patient, testing for skin sensitization, and irritabilities.  

ISO 15223 – Symbols to be used with information to be supplied by the manufacturer. This standard identifies symbols that are globally accepted to be used in a broad spectrum of medical devices. These symbols can be placed on the device, on the packaging, or on any accompanying information such as instructions for use.  

ISO 45001 – This standard outlines the requirements for occupational health and safety management systems that can be employed in the medical device industry to help reduce occupational risk.

Where do I get these standards?

Standards used to design and build medical devices need to be purchased, and you must always maintain the most current revision of that standard to ensure proper adherence to it. They can be purchased as electronic copies, or you can request a paper copy for your files. You can purchase them directly from the standard organization (ISO, IEC, ASTM, UL, etc.). There are also organizations services that will provide standards from many organizations, serving as your to be your one-stop shop.

How do I know when standards change?

The best way to manage how you receive information about changes to industry standards would be to implement an electronic standard tracking system. These systems help to:

  • Give you early notifications of changes
  • Mitigate your company's risk by ensuring you're up-to-date
  • Save you time by eliminating the tracking on your own
  • Ensure your standards are up-to-date

Using manual processes such as spreadsheets to manage standards updates can be difficult, time-consuming, and lead to compliance risks - especially when a high number of standards and markets are involved. There are a variety of standards management tools to help medtech companies monitor and manage global standards, including Rimsys.

How can Rimsys help?

Rimsys’ regulatory management software offers standards management to help you stay ahead of the mayhem by providing:  

  • Access to a library of over 1.6 million global standards through a partnership with IHS Markit
  • The ability to link standards to individual products to more easily assess the impact of changes across your product portfolio
  • Automatic alerts when standards are changed, superseded, or withdrawn to reduce compliance risks and enable faster reaction times
  • Bulk updates to your essential principles/GSPR tables when standards change for easier maintenance and compliance

For more information, visit www.rimsys.io/solutions/standards-management.

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