ISO 13485:2016​

ISO 13485:2016 has profound effect on the medical devices industry. In today’s medical supplies industry, the criteria of safe and effective medical devices are the key factors in ISO 13485:2016 Medical Devices Quality Management System towards meeting the stakeholders’ expectations. It is the basis for setting of strategies and objectives, the improvement of processes, the measurement and overall improvement in areas essential to an organization’s operational efficiency and compliance with statutory and legal requirements.

Who?

Is this for you?

Any businesses involved in the supply chain of medical devices. This is particularly applicable for those that design, develop, manufacture, assemble, distribute and carry the brand name of medical devices (Manufacturer, OEM Manufacturer, Brand Owner).

Why?

Benefits for your business

  • Improve your company’s credibility and image. 
  • Improve customer satisfaction and confidence.
  • Improve your processes. 
  • Improve decision-making. 
  • Create a culture of continual improvement. 
  • Increase customer satisfaction and confidence.
  • Enhance and strengthen the organization’s image and positioning in the local/ global market.
  • Organization is aware of its role and commitment to raising the bar on the quality of products and services with better employee engagement.

The Key Elements of ISO 13485

Quality Management System (QMS)

Management responsibility

Resource management

Product realization

Measurement, analysis, improvement

How can Aegis Support?

5 Simple Steps to Certification

One-to-one Consultation Modelling

Allow us the opportunity to better understand your needs and expectations.‎
Buzz us for the complimentary 1-1 private consultation with the consultant.‎

Identifying Gap & Awareness

We identify the gaps within your organization against the international standards and ensure your team members do not just implement the system but able to sustain it for continual improvements (even after being certified). ‎

Documentation Preparation & Implementation

We design and customize documentation that suits your business needs. We want to ensure and prepare you ahead with the right steps for effective implementation.‎

Internal & External Audit​

We review and ensure the established Management Systems are in compliance with international standards prior to internal and external audits. We support your organization up to successful certification.‎

Get Certified and Showcase ​

Impress your stakeholders with your achievement! ‎

Interested in how we can help your core team improve and align?