At Triteq, we don’t just tick the boxes because we have to.
Regulatory standards are embedded throughout our product design process.

We design and develop complex, innovative products and systems, which require expert knowledge of relevant regulatory criteria. When vital decisions need to be made, we make sure that every aspect of regulatory compliance, relevant to your product is understood.

We carry out conformity assessments and manage the process for all aspects of CE Marking, ATEX and safety critical medical device approval.

Our accumulated experience of how to make products happen ensures we support our clients from innovation to market, concept to product and service to adoption. New requirements for ISO14001, 9001 and 13485 come into effect September 2018. Triteq already has all the new documentation in place for all of these changes and we are engaging with BSI on an audit schedule to verify these requirements. The changes place greater emphasis on risks and opportunities for companies.

We are audited by BSI to three individual standards:

ISO13485

The internationally recognized quality management systems standard for the medical device industry.

  • ISO 13485 ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
  • To address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
  • Designed for regulatory compliance.

ISO9001

A business management improvement tool.

  • Demonstrates your commitment to quality products and services.
  • The most widely recognized international management system standard.
  • Helps safeguard the quality of your products and services

ISO14001

“The world’s most recognized environmental management system”

  • ISO 14001 helps businesses of all sizes across all sectors make their day to day operations more sustainable.
  • How to consider multiple aspects of your business procurement, storage, distribution, product development, manufacturing.
  • Evaluate how you manage emergency response, customer expectations, stakeholders and your relationships with your local community.

Visit the BSI website for more information. To talk to Triteq about our accreditations and regulatory compliance, contact us today.

 

product design & development for:

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