ISO 13485 : 2016 – Certification

Medical Devices

ISO 13485 Certification In Australia

Benefits of Obtaining ISO 13485

Obtaining ISO 13485 certification can provide several benefits to organizations operating in the medical device industry. Here are some of the key advantages: Actual benefits realized may vary depending on the organization’s size, industry, and specific implementation. Additionally, the benefits are not limited to the ones mentioned below, as they can vary depending on the organization’s unique circumstances and objectives.

What is ISO 13485 Certification?

ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) for medical devices.

 It is specifically designed to address the unique needs of the medical device industry and ensure compliance with regulatory requirements.


Frequently Asked Question

ISO 13485:2016 certification is not mandatory; although it brings your practices up to date with standard requirements that exist across the country, the EU and globally which very well may be mandatory.

Companies manufacturing medical devices often find that the consultancy of expert specialist helps them to easily implement ISO 13485:2016 into their core processes.

At Universal ISO, our consultants work directly with you to ensure your QMS works for your organization. We help you design your control requirements in line with the standard, then submit you to a recognized, third-party certification body who will audit your business and get you ISO 13485:2016 certified.

The time taken to get ISO 13485:2016 certified depends on the size, nature and complexity of your organization. It is estimated that it can take 6-8 weeks for companies with less than 50 employees. For larger companies, it can take 10-12 weeks as complex manufacturing processes like sterilization time consuming process.

Guarantee Success With 100% First-Time Certification

Share with :

What Client Says About Us

Don’t just take our word for it. Hear what our clients have to say about their experience working with us:

"Accurate Global ensured our project met industry standards flawlessly. Their certification process was efficient and precise, giving us the competitive edge we needed. Highly recommended!"

- Sarah M.

Choosing Accurate Global was a game-changer for our business. Their certification expertise elevated our credibility, attracting new clients and opportunities. Thank you, Accurate Global!"

- Mark T.

"Accurate Global's certification services surpassed expectations. They guided us throughout the process, delivering results that impressed our stakeholders. Trustworthy and reliable!"

- Lisa R.

"Impressed by Accurate Global's dedication to excellence. They meticulously certified our project, assuring top-notch quality and compliance. A valuable partner indeed!"

- Jason H.

"Accurate Global's certification played a pivotal role in our project's success. Their streamlined approach saved time and resources, giving us the green light to move forward confidently."

- Emma L.

Connect with Our Experts!

Achieve compliance and secure your business with Accurate Global.  Our team of experts will help you achieve and maintain the certifications you need to excel in today’s competitive landscape.


Level 13, 50 Cavil Avenue, Surfers Paradise, Gold Coast, Queensland 4217

Contact E-Mail

Our diverse range of clients from various industries

We proudly serve a diverse range of clients from various industries, including manufacturing, healthcare, technology, finance, and more. Here are some of the esteemed organizations we have had the privilege to work with: