--- title: ISO 13485:2016 Certification Coming Soon | Butler Technologies description: Learn what ISO 13485 certification means for medical device manufacturers and how Butler Technologies ensures quality, safety, and regulatory compliance in every product. Read now for more! image: https://butlertechnologies.com/hubfs/certification_coming_soon.jpg --- [![Butlertechnologies Logo](https://butlertechnologies.com/hubfs/butlertechnologies_logo.svg "Butlertechnologies Logo")](https://butlertechnologies.com/) - Who We Are - [About Us](https://butlertechnologies.com/about-us) - [Careers](https://butlertechnologies.com/careers) - [Certifications & Approvals](https://butlertechnologies.com/certifications-approvals) - What We Do - What Services We Offer - [Full-Scale Production](https://butlertechnologies.com/full-scale-production) - [Design](https://butlertechnologies.com/design) - [Innovation & Prototyping](https://butlertechnologies.com/innovation-prototyping) - [Our User Interface Components](https://butlertechnologies.com/user-interface-components) - [Membrane Switches & Keypads](https://butlertechnologies.com/membrane-switches) - [Graphic Overlays & Labels](https://butlertechnologies.com/graphic-overlays) - [Dials & Gauges](https://butlertechnologies.com/dials-gauges) - [Touch Screens](https://butlertechnologies.com/touch-screens) - [Gaskets, Filters, Barriers](https://butlertechnologies.com/gaskets-filters-barriers) - [Our Advanced Printed Technology](https://butlertechnologies.com/advanced-printed-technology) - [Biometric Sensors](https://butlertechnologies.com/biometric-sensors) - [Force Sensing Resistors](https://butlertechnologies.com/force-sensing-resistors) - [Flexible Heaters](https://butlertechnologies.com/flexible-heaters) - Why Choose Us - [Industry Experience](https://butlertechnologies.com/industries) - [Customer Journey](https://butlertechnologies.com/customer-journey) - [Customer Satisfaction](https://butlertechnologies.com/customer-satisfaction) - [Custom Capabilities](https://butlertechnologies.com/custom-capabilities) - [Certifications & Approvals](https://butlertechnologies.com/certifications-approvals) - Resources - [Blog](https://butlertechnologies.com/blog) - [News](https://butlertechnologies.com/blog/tag/news) - [Downloadable Resources](https://butlertechnologies.com/downloadable-resources) - [For Customers](https://butlertechnologies.com/customer-resources) - [FAQs](https://butlertechnologies.com/faqs) - [Contact Us](https://butlertechnologies.com/contact-us) - [Request A Quote](https://butlertechnologies.com/request-quote) # Blog & News # ISO 13485:2016 Certification Coming Soon Posted by [Butler Technologies](https://butlertechnologies.com/blog/author/butler-technologies) on October 30, 2020 Explore expert insights from Butler Technologies. Read blogs on printed electronics, user interface solutions, and innovative technologies shaping the industry. - [Tweet](https://twitter.com/share) > # [“Safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485.” – International Organization for Standardization](https://www.iso.org/iso-13485-medical-devices.html) ## ![ISO 13485:2016 certification logo on a white background with blue text](https://butlertechnologies.com/hs-fs/hubfs/%F0%9F%92%BB%20Website/Imported_Blog_Media/iso-logo-400x216-1-2.jpg?width=400&height=216&name=iso-logo-400x216-1-2.jpg)What is ISO-13485 for? [ISO 13485](https://www.iso.org/iso-13485-medical-devices.html) is a quality management system, with a specific focus on the medical industry. It represents the requirements for a quality management system (QMS) for the design and manufacture of medical devices. It was created to help ensure the safe design, manufacture, and distribution of medical devices. It also helps to create a globally adopted model of QMS requirements. Although it was first published in 1996, it has been continually improved upon over the last 24 years. The newest standard is ISO 13485-2016. All ISO standards are reviewed every five years to establish whether revisions need to be made. This helps to keep the standard relevant and up to date with the latest quality standards and QMS practices. In the 2016 updated standard, there is a greater emphasis on risk-based decision making and risk management. Examples of some of the most recent changes with regards to risk management are as follows: - Training of employees - Software - Monitoring, testing, and traceability - Management of both corrective and preventative action [(CAPA)](https://www.mastercontrol.com/quality/capa-software/corrective-action-capa-software/) - Outsourcing and supplier control ## What can be classified as a Medical Device? Medical Devices are instruments that are intended to diagnose, treat, or prevent diseases or any other medical condition. Products that would be classified as Medical Devices would be those such as an instrument, machine, in vitro reagent, or implant. However, in the case of [BTI](https://butlertechnologies.com/), it would be any [medical machine](https://butlertechnologies.com/blog/the-lifecycle-of-medical-equipment) or instrument. ## ![medical device in a hospital setting](https://butlertechnologies.com/hs-fs/hubfs/%F0%9F%92%BB%20Website/Imported_Blog_Media/Medical-Device-3-4.jpg?width=600&height=400&name=Medical-Device-3-4.jpg) ## Why BTI is Getting ISO 13485 Certified At Butler Technologies, we believe that quality is the single-most-important standard to implement within our company culture. Although ISO 13485 is not a *required* certification, it goes hand-in-hand with our current ISO 9001-2015 certification with design. ISO 9001 sets the criteria for a quality management system. When certified, you must continually show that you are adopting better quality standards within your organization. As stated by [ISO,](https://www.iso.org/iso-9001-quality-management.html) ISO 9001 “helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits”. Because our company is constantly striving to adopt better quality standards, we felt it was only right to continue to do so in every aspect. As we shift further into the medical device industry, we want to ensure we are following the best quality standards, as well. ## Our Adoption of ISO 13485’s Benefit to You Although there are distinct benefits of getting ISO 13485 certified for our organization, there are also distinct benefits for our customers. Some of the benefits are as follows: ### !["quality is the best business plan" printed onto a square block of wood](https://butlertechnologies.com/hs-fs/hubfs/%F0%9F%92%BB%20Website/Imported_Blog_Media/Quality-is-the-best-business-plan-320x400-1-2.png?width=320&height=400&name=Quality-is-the-best-business-plan-320x400-1-2.png)1.     Better Quality Products Better quality products will be a key benefit for you and your team. As better-quality standards are implemented, better quality products are bound to follow. ### 2.     Safer Products Because better quality standards will be put into place, you will also get safer products. There will be a set of best practices for creating each component for your medical device. ### 3.     Consistent Product Design & Production With a QMS system in place, consistency will also be a key benefit. Your product will be created with the same process each time, meaning a more consistent design, and production for your product. ### 4.     Faster Cycle Times & Better Service Faster cycle times will be a key benefit of adopting ISO 13485, as your production, processes, and system are under constant review. Quality can lead to faster cycle times, and ultimately better service for our customers. ISO 13485 is an essential certification when it comes to quality management within an organization. Stay tuned, as [Butler Technologies](https://butlertechnologies.com/contact-us) is in the process of getting ISO 13485 certified. We’re excited to see where this certification will take our team as we dive deeper into the production of medical devices.   ## ![Headshot of a digital marketing specialist smiling outside on a brick wall.](https://butlertechnologies.com/hs-fs/hubfs/%F0%9F%92%BB%20Website/Imported_Blog_Media/Untitled-design-9-400x400-Dec-22-2022-12-17-21-9990-PM-Dec-23-2022-07-59-31-3145-AM.jpg?width=334&height=334&name=Untitled-design-9-400x400-Dec-22-2022-12-17-21-9990-PM-Dec-23-2022-07-59-31-3145-AM.jpg)Meet the Author: Jaclyn King Jaclyn is a Digital Marketing Specialist on the BTI Team. She serves as the Content Manager, where she primarily manages social media channels, SEO, Public Relations, and website development. To get to know more about Jaclyn, check her out on LinkedIn!   Topics: [News](https://butlertechnologies.com/blog/tag/news) Table of Contents ### Categories - [Advanced Printed Technology (76)](https://butlertechnologies.com/blog/tag/advanced-printed-technology) - [Auto & Marine (6)](https://butlertechnologies.com/blog/tag/auto-marine) - [Biometric Sensors (29)](https://butlertechnologies.com/blog/tag/biometric-sensors) - [Consumer Goods (8)](https://butlertechnologies.com/blog/tag/consumer-goods) - [Dials & Gauges (7)](https://butlertechnologies.com/blog/tag/dials-gauges) - [Filters & Barriers (2)](https://butlertechnologies.com/blog/tag/filters-barriers) - [Flexible Heaters (30)](https://butlertechnologies.com/blog/tag/flexible-heaters) - [Force Sensing Resistors (21)](https://butlertechnologies.com/blog/tag/force-sensing-resistors) - [Full Scale Production (3)](https://butlertechnologies.com/blog/tag/full-scale-production) - [Gaskets (3)](https://butlertechnologies.com/blog/tag/gaskets) - [Graphic Overlays (23)](https://butlertechnologies.com/blog/tag/graphic-overlays) - [Heavy Equipment & Utility Vehicles (7)](https://butlertechnologies.com/blog/tag/heavy-equipment-utility-vehicles) - [HMI (17)](https://butlertechnologies.com/blog/tag/hmi) - [Industrial Controls (7)](https://butlertechnologies.com/blog/tag/industrial-controls) - [Innovation (24)](https://butlertechnologies.com/blog/tag/innovation) - [Manufacturing & Design (64)](https://butlertechnologies.com/blog/tag/manufacturing-design) - [Medical (39)](https://butlertechnologies.com/blog/tag/medical) - [Membrane Switches & Keypads (28)](https://butlertechnologies.com/blog/tag/membrane-switches-keypads) - [Military & Defense (8)](https://butlertechnologies.com/blog/tag/military-defense) - [News (19)](https://butlertechnologies.com/blog/tag/news) - [Outdoor & Athletic Apparel (22)](https://butlertechnologies.com/blog/tag/outdoor-athletic-apparel) - [Printed Antennas (3)](https://butlertechnologies.com/blog/tag/printed-antennas) - [Proof of Concept (1)](https://butlertechnologies.com/blog/tag/proof-of-concept) - [Prototyping (1)](https://butlertechnologies.com/blog/tag/prototyping) - [Safety & Personal Test Equipment (4)](https://butlertechnologies.com/blog/tag/safety-personal-test-equipment) - [Touch Screens (17)](https://butlertechnologies.com/blog/tag/touch-screens) - [User Interface (42)](https://butlertechnologies.com/blog/tag/user-interface) - [White Goods (2)](https://butlertechnologies.com/blog/tag/white-goods) See all ## Where to start With all the different customization options and use cases, it might seem overwhelming. Contact our expert team today and take the pressure off yourself. ## Let’s Work Together - [About Us](https://butlertechnologies.com/about-us) - [Custom Capabilities](https://butlertechnologies.com/custom-capabilities) - [Industry Experience](https://butlertechnologies.com/industries) - [Contact Us](https://butlertechnologies.com/contact-us) Search ### follow us - - - - - - ![lets_work_2015](https://butlertechnologies.com/hubfs/lets_work_2015.png) ### phone [(724) 508-2016](tel:724-508-2016) ### address [231 West Wayne St. Butler, PA 16001, USA](https://goo.gl/maps/KpvhJSWBtkyPFKFZ7) ### Hours of operation 7:30-4:30 PM EST Monday – Friday © 2026 [Butler Technologies](https://butlertechnologies.com/) | [Terms and Conditions](https://butlertechnologies.com/terms-and-conditions) | [Privacy Policy](https://butlertechnologies.com/privacy-policy) to the top ```json { "@context" : "https://schema.org", "@type" : "BlogPosting", "author" : { "@type" : "Person", "name" : "Butler Technologies", "url" : "https://butlertechnologies.com/blog/author/butler-technologies" }, "dateModified" : "2025-09-11T07:43:08.925Z", "datePublished" : "2020-10-30T04:00:00.000Z", "headline" : "ISO 13485:2016 Certification Coming Soon | Butler Technologies", "image" : [ "https://butlertechnologies.com/hubfs/certification_coming_soon.jpg" ], "mainEntityOfPage" : { "@id" : "https://butlertechnologies.com/blog/iso-13485-certification", "@type" : "WebPage" }, "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "url" : "https://butlertechnologies.com/hubfs/%F0%9F%92%9A%20BTI%20Brand%20Elements%20and%20Logos/NEW%20BTI%20Logo%20Final.png" }, "name" : "Butler Technologies Inc" } } ``` ```json { "@context" : "https://schema.org", "@id" : "https://butlertechnologies.com/blog/#webpage", "@type" : "WebPage", "about" : { "@id" : "https://butlertechnologies.com/#organization" }, "description" : "Explore the Butler Technologies blog for insights on printed electronics, user interface components, advanced printed technology, and industrial innovation.", "inLanguage" : "en-US", "isPartOf" : { "@id" : "https://butlertechnologies.com/#website" }, "mainEntity" : { "@id" : "https://butlertechnologies.com/blog/#blog" }, "name" : "Butler Technologies Blog", "url" : "https://butlertechnologies.com/blog/" } ``` ```json { "@context" : "https://schema.org", "@id" : "https://butlertechnologies.com/blog/#blog", "@type" : "Blog", "description" : "Articles and insights from Butler Technologies focused on printed electronics, membrane switches, biometric sensors, force sensing resistors, flexible heaters, and related technologies.", "inLanguage" : "en-US", "name" : "Butler Technologies Blog", "publisher" : { "@id" : "https://butlertechnologies.com/#organization" }, "url" : "https://butlertechnologies.com/blog/" } ``` ```json { "@context" : "https://schema.org", "@id" : "https://butlertechnologies.com/blog/#itemlist", "@type" : "ItemList", "itemListElement" : [ { "@type" : "ListItem", "name" : "How Force Sensing Resistors Convert Pressure Into Electrical Signals", "position" : 1, "url" : "https://butlertechnologies.com/blog/how-force-sensing-resistors-convert-pressure-to-electrical-signal" }, { "@type" : "ListItem", "name" : "When Engineering Meets Purpose: Why PaceAid Matters to Butler Technologies", "position" : 2, "url" : "https://butlertechnologies.com/blog/when-engineering-meets-purpose-why-paceaid-matters-to-butler-technologies" }, { "@type" : "ListItem", "name" : "How Printed Biometric Sensors Capture and Transmit Bioelectric Signals", "position" : 3, "url" : "https://butlertechnologies.com/blog/how-printed-biometric-sensors-capture-bioelectric-signals" } ], "itemListOrder" : "https://schema.org/ItemListOrderDescending", "name" : "Latest Blog Articles", "numberOfItems" : 3 } ``` ```json { "@context" : "https://schema.org", "@id" : "https://butlertechnologies.com/blog/#breadcrumb", "@type" : "BreadcrumbList", "itemListElement" : [ { "@type" : "ListItem", "item" : "https://butlertechnologies.com/", "name" : "Home", "position" : 1 }, { "@type" : "ListItem", "item" : "https://butlertechnologies.com/blog/", "name" : "Blog", "position" : 2 } ] } ```