TRISKELE CONSULTING

Sooner or later (sooner is better!), you will need to implement a Quality Management System (QMS). Triskele Consulting Ltd has experience in delivering new and bespoke Quality Management Systems built from the ground up to meet the requirements of EN ISO 13485 (European Union) and 21 CFR 820 (USA). We can provide you with a QMS package with the required procedural templates to demonstrate that you COMPLY with the applicable regulations to deliver QMS certification- usually a pre-requisite to regulatory approvals... Triskele Consulting provides design & development, quality systems/compliance and regulatory support to both new and established medical device companies. With niche expertise in active devices, active implantable devices, implantable and invasive devices combined with specialist knowledge of the related sterilization requirements, Triskele Consulting develops and delivers the strategy to get your product to market and maintain its compliance in the increasingly regulated..

Also known as: Triskele Consulting Limited, Triskele Consulting Ltd