ISO 9001:2008
Quality Management System:

ISO 9001: 2008 defines quality as ‘the degree to which a set of inherent characteristics fulfils requirements.’ Grade denotes a category or grade attributed to a product, and grades and categories of products having the same functional use can be widely different.
ISO 13485


ISO 13485 is the international standard recognized for medical device regulations around the world. It is intended to promote harmonisation in the medical device industry and set a basis for quality system regulations worldwide.
ISO 14001:2004
Environmental Management System:

EMS defines an effective environmental system which can be applied to all types of companies. Environmental issues have come to the forefront in recent years with greater awareness amongst legislators, insurers, financiers...
ISO 13485

ISO 13485 is the international standard recognized for medical device regulations around the world.
It is intended to promote harmonisation in the medical device industry and set a basis for quality system regulations worldwide. We provide services that help manufacturers understand what they need to do to place compliant devices on markets throughout the world.
ISO 13485:2003 is the latest version of ISO 13485, published in July 2003. This standard is based on the ISO 9001:2000 process model approach. All requirements of ISO 13485 are specific to organisations providing medical devices, regardless of the type or size of the organisation.
• Manufacturers of high-risk medical products must be associated with a notified body to vouch for the product's quality. This is achieved through product testing and auditing of the manufacturer's quality management system.
• Whatever devices you produce, as a medical device manufacturer you have a responsibility to consistently deliver devices that are safe and effective.
• Adoption of this standard assures the customers that the product complies with all relevant product and service-oriented technical standards and regulations