The Assurance of ISO Accreditation

The Assurance of ISO Accreditation

When it comes to medical devices, trust, quality, and compliance are non-negotiable. At Omnimed, we’re committed to exceeding expectations, and our ISO 13485:2016 accreditation is a testament to that. This globally recognised standard ensures that every product and service we provide meets the highest levels of safety, reliability, and regulatory compliance, giving you complete confidence in choosing us as your supplier.


What is ISO 13485:2016?

ISO 13485:2016 outlines the requirements for a quality management system where organisations demonstrate their ability to deliver medical devices and related services that meet customer and regulatory needs. It applies to all stages of a medical device’s lifecycle, including design, production, storage, distribution, and servicing.

At Omnimed, we believe that holding the relevant accreditations is an important part of being a trustworthy supplier.


Why Customer Feedback Matters

As part of our commitment to continuous improvement and compliance with ISO 13485:2016, we value your feedback on our products and services. Customer insights are essential in helping us monitor, enhance, and ensure the effectiveness of the devices we provide.

With recent changes to The Medical Devices (Post-Market Surveillance Requirements), your feedback is now more important than ever. It allows us to maintain the highest standards, keep up with regulatory updates, and ensure our products consistently deliver quality and reliability.

We kindly ask you to share your thoughts through our quick surveys:

Product Experience survey (1 min)
Product Evaluation survey (5 mins)

Your feedback not only helps us meet regulatory requirements but also enables us to continue improving and refining our products to better serve you.


What This Means for You

Choosing Omnimed means partnering with a supplier that prioritises:

  • Uncompromising quality: Every product is designed, developed, and delivered to meet strict safety and reliability standards.
  • Regulatory confidence: Full compliance with medical device regulations.
  • Customer satisfaction: Solutions tailored to meet your specific needs, backed by a commitment to ongoing improvement.
  • Traceability and risk management: Comprehensive systems ensure consistency, reliability, and swift resolution if issues arise.

Working Together

At Omnimed, we believe in building strong relationships with our customers by listening, learning, and improving together. Your feedback plays a crucial role in this process, enabling us to deliver products that support exceptional care in the medical field. Thank you for helping us maintain the high standards you expect.

Let’s continue to make healthcare better, together.

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