what we do
Regulatory expectations for quality and compliance have never been higher.
Device Quality Limited can help you meet and exceed those expectations - quickly and efficiently.
PROCESS DEVELOPMENT & IMPLEMENTATION
We excel in the development of ISO 13485:2016 and MDR 2017/745/EU-compliant risk-based QMS processes following extensive stakeholder consultation and alignment.
Our technical expertise in implantable active medical devices and structural heart devices allows us to deliver real results for our clients in
• new product development and transfer to manufacturing
• change controls
• design controls and quality assurance
• internal audit programmes and CAPA ownership
• supplier quality management
LEAN - AGILE - EFFICIENT
As a consultancy, we understand the need to be lean and agile to meet our clients’ requirements. We can slot into your existing teams as a contingent resource or we can take total project ownership and immediately deliver results using a broad suite of project management skills.
We have worked with clinical-phase start-ups and multinational medical device manufacturers and we know how to deliver solutions tailored to your business needs.
PRODUCT TESTING & FAILURE ANALYSIS
We can help you meet you meet your product testing needs including hardware / software failure analysis and product compliance testing, including
• standards analysis (e.g. 60601-1, 60601-1-2)
• test strategy development
• interactions with external test facilities
• test protocol and test report authoring
• technical file generation for Radio Equipment Directive (2014/53/EU) compliance
