---
title: "ISO 13485:2016 — Medical Devices"
description: "ISO 13485:2016 consulting. Implement a Quality Management System for medical devices aligned with regulatory requirements."
url: https://summaq.com/en/standards/iso-13485
language: en
---

# ISO 13485:2016 — Medical Devices

ISO 13485:2016 is the international standard for Quality Management Systems for organizations that design, manufacture, distribute, or service medical devices, with a central focus on patient safety and regulatory compliance.

## What is ISO 13485:2016?

While it shares a structure with [ISO 9001](/en/standards/iso-9001), the standard has stricter requirements of its own: full product traceability, risk management across the device's entire life cycle, control of sterilization and clean environments, and a direct link to each market's regulatory requirements (COFEPRIS, FDA, the EU Medical Device Regulation, among others).

In many markets, certification is a mandatory prerequisite to commercialize medical devices, not just a competitive advantage.

## Benefits of certification

- Access to markets and clients that require certification as a regulatory condition.
- Full product traceability for health authorities and customers.
- Formal risk management across the device's entire life cycle.
- Lower likelihood of product recalls and regulatory non-conformities.
- A solid foundation for regulatory registration processes across different countries.

## Who it applies to

It applies to medical device manufacturers, critical component suppliers, distributors, and associated service providers (sterilization, calibration, maintenance) within the healthcare supply chain.

## How we support you

**Regulatory diagnosis** — We identify the applicable requirements based on your product, risk class and target markets.

**Implementation** — We design the QMS, product risk management and the traceability controls required.

**Certification** — We support you through the certification audit and maintaining the system through regulatory audits.

**Medical device specialization**

We combine our [ISO 9001](/en/standards/iso-9001) expertise with regulatory knowledge specific to the healthcare sector.

Contact: contacto@summaq.com · https://summaq.com/en/contact