We are delighted to have been awarded our ISO 13485 certificate. It is an internationally recognised standard for quality management systems specific to the medical device industry. Here’s a breakdown of what it means and what it allows you to do:

What is ISO 13485?

ISO 13485 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. It is designed to be used by organisations involved in the design, production, installation, and servicing of medical devices, as well as the provision of related services.

Key Aspects of ISO 13485:

  1. Quality Management System (QMS): It outlines the criteria for a comprehensive QMS tailored to the medical device industry.
  2. Regulatory Compliance: Ensures that organisations comply with regulatory requirements relevant to the production and distribution of medical devices.
  3. Risk Management: Focuses on identifying and managing risks associated with the production and use of medical devices.
  4. Product Development: Establishes controls for the entire lifecycle of a medical device, from design and development to production, distribution, and post-market activities.
  5. Customer Satisfaction: Aims to consistently meet customer and regulatory requirements, enhancing customer satisfaction.

What ISO 13485 Certification Allows You to Do:

  1. Market Access: Facilitates access to international markets where compliance with ISO 13485 is often a regulatory or customer requirement.
  2. Regulatory Approvals: Supports meeting regulatory requirements, which can expedite product approvals and market entry.
  3. Quality Assurance: Demonstrates commitment to quality, improving product reliability and safety, and potentially reducing liability risks.
  4. Competitive Advantage: Enhances reputation and credibility, making it easier to attract customers and business partners.
  5. Operational Efficiency: Streamlines processes and reduces inefficiencies, which can lead to cost savings and improved product quality.
  6. Customer Trust: Builds trust with customers and stakeholders by showing dedication to maintaining high standards in the design, production, and servicing of medical devices.

In summary, ISO 13485 certification means that our medical device meets the necessary quality and regulatory requirements, paving the way for greater market acceptance and customer confidence.