91³Ô¹ÏÍø

91³Ô¹ÏÍøQuality Overview

91³Ô¹ÏÍøLimited is accredited to ISO 13485, the International Standard for Quality Management Systems for medical device companies. As well as this 91³Ô¹ÏÍøLimited is accredited to MDSAP (Medical Device Single Audit Programme) demonstrating that the company has been audited and conforms with, as well as ISO 13485:2016, Australia – Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6) – Full Quality Assurance Procedure, Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 3 Part 4 – Production Quality Assurance Procedure; Brazil – RDC ANVISA n.16/2013, RDC ANVISA n. 23/2012, RDC ANVISA n. 67/2009; Canada Medical Device Regulations – Part 1 – SOR 98/282; Japan – MHLW Ministerial Ordinance 169, Article 4 to 68, PMD Act AND USA – 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D

Quality Assurance indicates our firm commitment to producing quality products. The quality assurance team maintain continuous quality audits on all production lines to ensure consistency to the highest standards. Continuous checks are carried out at every stage of production by roving inspectors and at static inspection points.

The QA/RA Systems Manager, Product Quality Manager, and team deal promptly with any customer complaints or quality issues that may arise. The team are there to also discuss, any aspects of the product or Quality Management System.