what is iso 13485

What is ISO 13485 - the Quality Management System for Medical Devices


In the dynamic landscape of medical device innovation, precision, and quality are paramount. At Elecrow, our latest campaign tailor-made for medical device-related projects is at its zenith. Explore a spectrum of cutting-edge services, all backed by the ISO 13485:2016 certification, designed to ensure the safety and effectiveness of your projects.

But what is ISO 13485 certification and why it’s important for the medical industry? If you are interested in these questions, come and dive into the blog together.


What is the Current Version of ISO 13485?

ISO 13485 is a standard for Quality Management Systems in the field of medical devices. It was published by the International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design, development, manufacture, and installation of medical devices. 

The latest revision of ISO 13485 for medical devices was published on 1 March 2016. As requirements for regulatory purposes, ISO 13485:2016 is made up of eight sections, namely,

  • Scope
  • Normative References
  • Terms and Definitions
  • Quality Management System
  • Management Responsibility
  • Resource Management
  • Product Realization
  • Measurement, Analysis, and Improvement

The first three sections are introductory, and the last five contain the mandatory requirements for the Quality Management System. Click here to see the detailed clause.


What is the Importance of ISO 13485?

Since ISO 13485 provides a framework for ensuring medical devices consistently meet regulatory and customer requirements, the certification plays a vital role for medical device manufacturers. Therefore, compliance with ISO 13485 demonstrates a company's commitment to producing safe and effective medical devices. It also helps companies meet regulatory requirements in many markets around the world. ISO 13485 can help companies identify and mitigate risks associated with the design, development, production, and installation of medical devices. Finally, it can help companies improve their manufacturing processes and increase efficiency, leading to better products and higher customer satisfaction.


What Elecrow Offers for ISO 13485-Certified Medical Devices

Precision at Every Layer - PCB Prototype

Unlock the potential of your medical device prototypes with Elecrow's exclusive PCB Prototype offer. Receive 5 pieces of 1-2 layer PCBs for just $1, featuring dimensions up to 30*30cm, HASL or lead-free HASL, and 1 oz PCB. Plus, enjoy a 10% discount on additional PCB orders, ensuring your prototypes meet the highest medical industry standards.

Clarity and Precision - Acrylic Laser Cutting

Experience precision with Elecrow's Acrylic Laser Cutting services. Obtain up to 5 transparent acrylic sheets for $1, with dimensions reaching 30*30cm and thickness options of 2mm or 3mm. Avail a 10% discount on other quantities and specifications, ensuring your medical device components are crystal clear and finely crafted.

Dimensional Freedom - 3D Printing

Elecrow brings your medical device visions to life with our 3D Printing services. Enjoy the 1 piece of 3D Printing for just $1, suitable for weights within 150g and material 9400. Elevate your designs and achieve unparalleled flexibility in product development.

Revolutionizing Assembly - PCBA Excellence

Power your medical device projects with Elecrow's PCBA services. Benefit from a free assembly fee for orders under 20 pieces, and incredible discounts of 40% and 50% for orders surpassing 20 and 200 pieces, respectively. Moreover, for total orders exceeding $1000, $2000, and $5000, receive extra gifts to complement your assembly process.


Let’s enjoy Elecrow's Special Offer for ISO 13485-Certified Medical Devices, advancing healthcare together!