REGULATORY
COMPLIANCE
Regulatory compliance is always a major consideration when developing products

Our team understands the need to meet the challenge of compliance, whilst also satisfying performance criteria demanded by the market. We have a strong commitment to external validation and this is an integral part of our development process.

As a designer and manufacturer of medical devices, Quadralene has many regulatory responsibilities. Our ISO 13485:2016 Quality Management System covers all of our design and manufacturing procedures and demonstrates our commitment and ability to deliver products and services that consistently meet the needs of our clients and the exacting regulatory standards across the different product types.

Regulatory compliance is always a major consideration when developing products

Our team understands the need to meet the challenge of compliance, whilst also satisfying performance criteria demanded by the market. We have a strong commitment to external validation and this is an integral part of our development process.

As a designer and manufacturer of medical devices, Quadralene has many regulatory responsibilities. Our ISO 13485:2016 Quality Management System covers all of our design and manufacturing procedures and demonstrates our commitment and ability to deliver products and services that consistently meet the needs of our clients and the exacting regulatory standards across the different product types.

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Quadralene Ltd
Bateman St
Derby DE23 8JL

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