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.
- Compliance with regulatory requirements for medical devices
- Enhanced product quality of medical devices
- Increased market access
- Improved internal processes
- Risk management and patient safety
- Supplier and stakeholder confidence
- Continuous improvement
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.
FAQ
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.
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