Quality Management System

Committed to quality

Advant Medical are committed to quality in everything we do. We have over 30+ years of experience in supplying the highest quality products to our customers. Certified ISO 13485:2016, our focus on quality ensures your products are of the highest industry standard.

Quality Management System | Advant Medical Quality Management System | Advant Medical

Lean Six Sigma Product & Process Development

Advant Medical nurture a Lean philosophy providing innovative and world-class manufacturing techniques. Consistently incorporating lean principles maximising efficiencies, eliminating waste and streamlining business processes, Advant effectively increases speed to market for our customers.

We are committed to delivering innovative solutions that deliver real advantages to our customers.

Supporting our Lean philosophy is a team who are certified and highly experienced in:

Lean Business Practices (LBP)
New Product Introduction (NPI)
Six Sigma Problem-Solving and Process Improvement

Risk-Based Validation – ISO 14971

At Advant Medical, our validations are performed in accordance with ISO 14971:2019 guidance. This risk-based approach ultimately safeguards the patient by producing components and devices that are safe, effective and meet our customers’ requirements.

Technical File and Design Dossier Submission Support

Advant Medical is experienced in Technical File and Design Dossier Compilation. We can support aspects of a customer’s submission, assisting and providing guidance in areas such as:

Medical Device Regulatory Requirements (ISO, MDD, 21CFR, USP, etc.)

Component Material Selection

Test Method Development

Risk Analysis Report (DFMEA, PFMEA, etc) (ISO 14971; GHTF Guidelines)

Sterilization Validation Planning (ISO 11137)

Packaging Testing (ISO 11607)

Integrated Quality System and Change Control

Advant Medical has developed a custom-built software solution to effectively control quality records and change control.

It is an integrated QMS that inclusively manages:


Documentation (SOPs, Forms, etc)
Non-Conformance Reporting
Customer Information


This system is validated to 21CFR Part 11 to comply with FDA requirements on electronic records.

ISO 13485: 2016 Accredited QMS

Advant Medical operates a Quality Management System which is accredited to

ISO 13485:2016 standard.

Advant Medical ISO 13485:2016 Certificate

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

Related Resources


Contract Manufacturing

Our Contract Manufacturing Brochure showcasing our capabilities in medical device manufacturing.



Advant Medical ISO 13485:2016 Certificate

View our most recent ISO 13485:2016 Certificate



Injection Moulding

Our Injection Moulding Brochure showcasing our capabilities in Injection Moulding.



Product Development

Our Product Development Brochure showcasing our capabilities in medical device product development.


Talk to Advant today