Comprehensive quality management and regulatory compliance for your device

We maintain a Quality Management System to control the design, development and manufacturing processes for products entering into worldwide markets

This system incorporates appropriate quality gates throughout the design and manufacturing process from supplier selection and qualification, through to final acceptance, device tracking and device maintenance.

Integrated Technologies Ltd is accredited and audited to:

Our quality system additionally incorporates BSEN ISO 14791, BSEN 62304 and BSEN 62366, amongst others, to ensure a fully compliant regulatory framework.

ITL works closely within the appropriate European CE marking directives including:

  • 93/42/EEC Medical Device Directive
  • 98/79/EC In-Vitro Diagnostics Directive
  • 2006/95/EC Low Voltage Directive
  • 2004/108/EC Electromagnetic Compatibility Directive
  • 2011/65/EU RoHS II Directive

Medical device regulatory consultancy

We also offer medical device development and regulatory consultancy, including pre-compliance safety and regulatory assessments, to assist you in your medical device product development project.

We have considerable experience in supporting our customers to achieve American Food & Drug Administration (FDA) 510k and Pre-Market Approvals (PMA).

Our Chinese facility also facilitiates China Food & Drug Administration (CFDA) applications.

Furthermore, we can help you to manage submissions and on-going factory audits for Nationally Recognised Testing Laboratories (NRTLs) including UL, CSA, ETL and MET (for US and Canadian market approval).

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News
ITL Group announced as British Excellence in Engineering Awards finalist

ITL Group celebrates after being shortlisted in the Consultancy of the Year category for the British Excellence in Engineering Awards (BEEAs) 2017.

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Resource
Advantages vs Disadvantages of 3D Printing in Research and Development

Despite 3D printing being a relatively young technology, it is fundamentally changing the way we prototype and test medical devices – but what are the advantages? Potential challenges? What impact will it have on medical device manufacturing?

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Case Study
Endomag

Read how ITL took the SentiMag® system from concept to volume manufacture.

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Case Study
Vivacta

Working to develop and prototype a Point-of-Care diagnostic device and microfluidic cartridge.

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