Commitment to
Quality

Delivering quality assured products and services since 1993

Maintaining product and process quality is at the heart of everything we do at Advant Medical

At Advant Medical, we have a longstanding commitment towards delivering high-quality products and components to the international medical device industry. Our capabilities range from the supply of a single component to the supply of Class I, II, III implantable devices to companies of all sizes.

With our ISO 13485: 2016 certified quality management system and Class 8 cleanroom manufacturing facilities, we strive to ensure our customers are provided with an end product that is safe, effective, meets regulatory requirements and promotes patient safety.

Risk-Based Validation

All our validations are performed in accordance with ISO 14971: 2019 guidance.

Lean Six Sigma Product & Process Development

By consistently incorporating Lean principles, our certified team of quality personnel strive to always ensure high quality and continuous improvement.

FDA Compliant

As a manufacturer of medical devices to the US market, the legal manufacturer is assured that we are FDA registered.

Turnkey solutions from design to manufacture

Since 1993 Advant Medical has been a Global Partner for Class I, II, III Medical Device Development & Manufacturing Solutions to many of the World’s Leading Medical Technology Companies. Our integrated quality and supply chain management systems gives us the confidence to deliver high quality medical devices.

Operating from our ISO Class 8 cleanroom facilities, we have an all-encompassing experienced team in various disciplines of 3D Printing, Injection Moulding, Product Development, Contract Manufacturing and Packaging services.

Conforming to packaging standard ISO 11607, our Class 8 facilities are equipped with the latest technology and experienced personnel to support your sterile packaging and manufacturing requirements.

Expertise, Commitment, Quality

Partnering with Advant Medical allows you to place trust in us. Our flexible and progressive approach to manufacturing, a long-standing commitment to quality and extensive industry experience allows us to support companies of all sizes with their low and high-volume manufacturing requirements.

ISO 13485: 2016 Accredited Quality System

Advant Medical operates a Quality Management System which is accredited to ISO 13485: 2016 standard.


Download and Print ISO Certification

FDA Registered

As a manufacturer of medical devices to the USA market, the legal manufacturer is assured that we are FDA compliant.


Click here to view our FDA registration

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