Quality management

We ensure your healthcare product meets industry standards and requirements, with quality management built in at each stage of the process

Global expertise

How do we ensure quality and regulatory compliance?

We take the safety, efficacy and quality of your product and supply chain seriously. Partner with us, and you’ll get access to our ISO 13485-certified Quality Management Systems across our FDA registered facilities in Europe, Asia and North America.

You’ll also get a proactive team that has decades of expertise in establishing bespoke controls for unique project specifications, providing regulatory consulting and delivering a broad range of validation services.

Find out how to comply with applicable regulatory requirements today
Compliance management and regulatory services

Certified to get your product to the finish line

In addition to our robust procedures, cleanroom environments and digital infrastructure, our teams stay up to date with the latest laws, regulations and governing standards. So they can give you guidance on regulatory submissions, sterilization management and test methods, dossier compilation, medical device classification and overall Quality Management System compliance.

  • Global regulatory agencies FDA, Health Canada & European Commission Authorities registered facilities
  • UDI packaging unique device identification for traceability & accuracy
  • Local market regulatory expertise consultancy & support
  • ISO 7 and ISO 8 cleanrooms

On-site testing and validation

We ensure you have the necessary evidence, documentation and controls in place for successful project compliance.

Our Design & Product Development studios house laboratories and test facilities for the selection and validation of optimal materials for use in products and packaging – including metrology, mechanical testing, environmental testing and electrostatic discharge (ESD) testing.

Our dedicated microbiological laboratory provides functional testing with custom-made testing jigs and equipment; 3D internal and external dimensional measurement and control; sterile barrier system testing; and bioburden, sterility and endotoxin testing.

End-to-end capability

You’ll find quality in everything we do

Discover all our capabilities, from design and product development to manufacturing, assembly, packing and sterilization management.

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⋮ Support Services

Find out how we support your design, manufacturing and packing needs with a comprehensive range of support services. We have global experts in everything from supply chain management, project management, quality and infrastructure – ready to provide guidance and ease your journey to market.

Capabilities:
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We can help you take the right steps forward

We’re here to help you make consistent, reliable and regulatory compliant products, that bring more patients high quality care.