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.
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:
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:
This system is validated to 21CFR Part 11 to comply with FDA requirements on electronic records.
Related Resources
Brochure
Contract Manufacturing
Our Contract Manufacturing Brochure showcasing our capabilities in medical device manufacturing.
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Certificate
Advant Medical ISO 13485:2016 Certificate
View our most recent ISO 13485:2016 Certificate
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Brochure
Injection Moulding
Our Injection Moulding Brochure showcasing our capabilities in Injection Moulding.
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Brochure
Product Development
Our Product Development Brochure showcasing our capabilities in medical device product development.
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