Medical Devices
ISO 13485
In medical matters, everybody insists on impeccable standards. ISO 13485 certification attests to the quality management systems used for medical devices – proving that people can have confidence in them.
As a medical provider, it is vital that you can demonstrate that your service or product is worthy of patients’ and service providers’ trust.
ISO 13485 adapts ISO 9001 quality management standards specifically for medical device manufacturers. It provides a comprehensive, clear and easily actionable audit to ensure the consistent design, development, production and installation of medical devices, demonstrating that they are safe for their intended purpose.
The ISO 13485 framework focuses on ensuring consistent quality, product safety and the sustainable success of your products or services.
Telarc’s expert team will make the experience of attaining ISO 13485 medical certification easy.
Key Benefits
- Improve risk management
- Ensure product quality and performance
- Meet regulatory requirements
- Gain market access
- Win the trust of patients and medical service providers.
How to achieve certification
Contact Telarc using our quote request form and we will help you through the process to achieve the certification(s) your organisation strives for.
The standards can be complex, but we’ve made it easy with simplified self-evaluation checklists that break down what you need to have implemented to meet the requirements of the standard. You can use the checklist to determine to what extent you already meet the requirements to become accredited, and which gaps need to be addressed.
Once you’re satisfied that your organisation meets the requirements, Telarc will audit your systems and either issue the certification or identify non-conformances that you need to address before certification is granted.
Read more on the certification process.
Why choose Telarc
Telarc is New Zealand’s largest auditing body for internationally recognised standards such as ISO, NZ Standards and industry-specific accreditations, including medical, forestry and a range of food safety certifications. We were founded as a Crown Entity in 1973, charged with conducting standards and certification audits to help businesses excel and improve.
Telarc uses expert, experienced auditors who are backed with the resources of an industryleading organisation. We are proactive in our approach, using our experience to suggest ways you can improve business performance. Throughout this process, we ensure that communication is clear and that we provide you with cost-effective direction that is practical to achieve.
Telarc enabled Alaron Products to acquire an ISO 13485 Medical Devices Certification within a quick period of time and without any issues.
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