Regulatory and Validation Services

Design, Tool, Process and Equipment Validation

Medical Device cleanroom

Validation Options

Europlaz offers a complete range of design, tool, process and equipment validation options to meet the various needs and expectations of its customers.

Process of Validation

Processes include:

  • Master Validation Plans
  • Validation Protocols (DQ, IS, OQ, PQ)
  • Process Failure Mode and Effects Analysis
  • Installation qualification
  • Design of Experiments
  • Operational qualification
  • Performance qualification
  • Product Characteristics Evaluation
  • Gauge R&R / Measurement system analysis
Validation
Please contact us to discuss your requirements or if you have any questions.

Latest News

Read more about our news on medical device manufacturing and development in the UK

COVID-19 Test Kits in Production

Endeavouring to play our part in the ongoing fight against COVID-19, we are delighted to announce that Europlaz has recently...

Europlaz signs COVID-19 Testing Contract Agreement

4th May 2020, Europlaz signs an agreement to manufacture COVID-19 Testing Kits. Further details to follow shortly.  

Innovative Home Dialysis System

Europlaz enters supply agreement to manufacture consumables for innovative home dialysis system Essex-based medical device supplier, Europlaz Technologies Ltd., has...