Quality is an important aspect of the Medical Devices industry. You may find that customers are often asking for proof of quality assurance from your organisation. Though you may practice quality management within your organisation, publically demonstrating that you follow an international standard of medical devices quality benchmark is another aspect.

The medical device manufacturing sector has become more regulated everyday in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce, and place onto the market, medical devices that are safe and fit for their intended purpose.

This means that it will get harder for you to manage the quality of your medical devices operation as you are forced to comply with more regulations everyday.

When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products. Ensuring effectiveness, control, and maintenance of your quality management system is critical to customers, stakeholders, and regulatory agencies.

ISO 13485 Medical Devices is a stand-alone quality management system Standard, and its purpose is to help you build a practical foundation to address the regulations, your responsibilities and your commitment to demonstrate the safety and quality of your medical devices.

The value of ISO 13485 Medical Devices is not just in the implementation, but also in providing a tool for a thorough audit of the system to test the effectiveness of the system. It provides the manufacturer a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements. Also it can help to minimize surprises and failures which might adversely affect patient safety and damage your reputation.

• Minimise potential quality issues with 3rd party audit
  Certification of ISO 13485 Medical Devices allows us to perform regular audit on your system to ensure that you are constantly in compliance with regulatory laws to minimise quality issues.
• Increase public image and accountability
  Certification demonstrate your commitment to quality assurance to your stakeholders and most importantly your potential customers.
• Increases responsiveness to issues and nonconformities
  Through regular audit, our Client Managers can help you identify weaknesses within your processes before a crisis appears and recommends the best solution to close the gap.

Being BSI certified with ISO 13485 means that you will get access to the exclusive BSI Certification Mark that will help you demonstrate your commitment to quality within the medical devices industry. The BSI Certification Mark is an internationally recognised mark in over 86 countries and being used by more than 80,000 customers worldwide.

In short, you will be assessed and certified by one of the world’s leader on Standards-based solution. Our experienced Client Managers will work closely with you to establish a proper framework.