Consultation

We offer a confidential and independent consultation service which allows healthcare companies to accelerate their product development plans.

Confidential & Independent Consultation Service

With our in depth knowledge of healthcare markets we have assisted medical device companies, large, small, and 'start-ups', to launch their products on a global scale, whether it's an injection moulded product, impantable or electromedical device.  All development processes are fully supported by technical authorship and documentation.

We work with designers, customer drawings and SLA prototypes, assist in material choice, component selection, right through to bespoke engineering solutions and tool design, including packaging design.  Our technical team have pratical experence in CE Marking medical devices, and also supporting 510k and PMA approvals for the USA.

We can independently source products and components, hold buffer stocks and help with new product introductions and assessing market needs. We can provide you with an effective regulatory service having registered Class I, Class IIa, Class IIb and Class III Devices.

We also provide an effective Quality Assurance service to assist you in the development of a regulatory compliant QMS. We hold a full range of certification and approvals for our Quality Management System, including ISO and FDA.

Validation Services

Our experienced Quality Department are here to help with your technical services and validations.  We offer comprehensive support and can project manage a range of activties including: -

  • Mechanical testing 
  • Cleaning validation 
  • Sterilisation validation - Vd-Max (Gamma, EB and EtO)
  • Dose Mapping
  • Routine dose audits and bioburden testing 
  • Seal integrity validation
  • Accelerated ageing and shelf life testing
  • Outsource QA and validation services

Our technical team can tailor validation needs to any specific validation requirements and we have access to independent testing laboratories to suit projects of all budgets.  We can compile technical reports, including presentation of the final results right through to CE marking.

Contact us for details »

Contact us

Please call our team on U.K. 0845 0739529, International +44 (0) 1527 830942 or fill in the form below, and we will be in touch at the earliest opportunity:

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Contamination Control

Contamination Control

Explore our InSpec product range for validated cleanroom contamination control solutions.

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