What ISO Standards Apply to Medical Devices?

As you may already know, Pathway Medtech provides 3 lines of services: medical design and engineering, manufacturing, and regulation. In particular, we work with startups (and seasoned medical device companies) looking for a one-stop shop for solutions. Consequently, this allows a seamless process that’s not disjointed, especially when it comes to assessing risk and implementing quality assurance practices to every medical device.

At Pathway Medtech, the medical device development life cycle begins with ideation/concept design. Using a powerful data collection and analysis tool known as design of experiments (DoE), our team establishes performance criteria, testing, and evaluation processes that are uniquely tailored to each proposed product. Activities related to manufacturing protocols are also addressed by identifying the equipment needed for production and formulating strategies to validate processes and controls, among other areas of consideration.

The FDA has a fiduciary responsibility to the public to only approve medical devices that are safe with limited risk. Thus Pathway Medtech collaborates with our clients to design, engineer, and manufacture products that meet the highest quality standards.

Before we delve into governmental mandates for production, let’s first clarify what the U.S. Food and Drug Administration (FDA) considers to be a “medical device.” According to Section 201(h) of the Food, Drug, and Cosmetic Act of 1938, the term may apply to “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory … intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.” The FDA also classifies certain software as eligible for medical device status if it is intended to be used for one or more medical purposes and can perform its function without being part of a hardware solution.

In the United States, medical device development is guided by ISO 13485 and ISO 14971 standards set forth by the International Organization for Standardization (ISO). These industry best practices establish a model for quality assurance by specifying performance criteria that ensure all necessary steps in the product life cycle are addressed—from design and development to production, installation, and service.

The International Organization for Standardization (ISO) is an independent, non-governmental entity that develops voluntary international standards.

ISO 13485, first published in 1996 and last revised in 2016, covers quality management systems for design and manufacturing. Basically, a quality management system defines the processes and procedures necessary to bring a specific product to market—including design controls, which demonstrate that a product design is safe and can fulfill its intended purpose.

ISO 14971, initially released in 2007 and most recently updated in 2019, deals with risk management methodologies, which can be integral to the quality management systems described in ISO 13485. Risk management is highly beneficial in helping manufacturers identify hazards, estimate and evaluate associated risks, and monitor the effectiveness of the controls that are in place.

Product conformity via ISO standards is vital to achieving a quality medical device capable of meeting today’s stringent health care standards supporting public well being.
It is also important to note that a quality management system, on its own, will not necessarily improve work processes or the final product. It merely facilitates a more systematic approach to fulfilling your organization’s objectives, which in turn should achieve such improvements.

What Are the Key Factors in Product Development?

When developing a medical device, it is important to identify the following basic answers:

• What problem will your device solve?
• Who is your intended end user?
• In which settings will your device be found?
• In what area of medicine can you market your medical device?

After establishing the product’s developmental parameters, you must then formulate an effective regulatory strategy to navigate FDA mandates for medical device compliance, and if applicable, the requirements involved in marketing a product in a foreign country. The latter consists of identifying rules for medical device deployment such as: classification categories, clearance/approval guidelines, notification and licensure requirements, and clinical evaluation data to demonstrate safety and performance. In some international markets, a local agent will need to be recruited to coordinate the registration of a medical device with regulatory authorities.

How Pathway Medtech Can Help

The regulatory strategy you choose can ultimately make or break the journey to market for a medical device product. Pathway Medtech’s proven ability to integrate design, regulatory strategy and manufacturing processes serves to optimize the entire team’s efforts and deliver quick, effective solutions to overcome any challenges along the way. This unified approach is unique to the medtech development industry and often shortens the overall FDA approval runway for clients.

Ready to get started, or just need help understanding your regulatory responsibilities? Contact us today for an initial consultation on your design development or manufacturing needs.