Medical Device Development

From Concept to Completion

Great Britian Flag

UK Based Medical Device Manufacturer

Europlaz is a UK based medical device supplier, located near London, which designs and delivers custom-configured instruments and medical devices. As your product development and outsourcing partner, we will use our vast, in-house capabilities and years of experience to take your project from an idea to a finished device.

Delivering Quality from Start to Finish

We understand that each customer is unique but the need for consistent supply of a quality product is universal.

As an FDA registered manufacturer, all Europlaz activities are supported by a six sigma and lean manufacturing culture and an appropriate and relevant QMS, based on the principles of:

ISO9001:2008

CE marking BS EN ISO:13485:2003

European Medical Device Directive 93/42/EEC

Canadian Medical Device Regulations SOR/98-282

FDA 21 CFR part 820 Quality system Regulations

Quality Control infographic
Medical Device cleanroom

Quality, Reliability and Value

Europlaz is committed to setting the benchmark for medical device design and manufacturing that exceed our customer expectations. We can do this by ensuring quality is at the heart of all that we do.

This is done by:

  • cGMP
  • Continuous improvement
  • Quality policy and objectives which are communicated to all levels of the organisation and supported with individual training plans
  • Regular maintenance of machines and the plant
  • Optimisation of all processes
  • Regular internal audits to complement our biannual external audits.
Man validating machine

Validation Services

Validation is key in order to ensure that a device and its associated manufacturing, assembly and test equipment are reliable and fit for purpose.

Europlaz have many years’ experience and can help ensure successful validation of your product. This includes full validation of mould tools, processes, equipment and creation of validation master plans.

medical device testing

In Process Testing

Quality laboratories which are fully equipped with the latest technical innovations, provide comprehensive support to the process management systems ensuring consistent product quality.

Medical Device Manufacturer

Established Quality Management System

Every member of the Europlaz team is expected to adhere to our strict quality management system and to go above and beyond for our customers and the team.
Our quality management system can be viewed as:

  • A common sense approach to the management of the organisation
  • Consistency
  • Continuous improvement of working practices
  • Getting it right first time
  • Keeping quality high and costs low
To understand how each of our capabilities fit together to form a complete medical device development process, please view our services pages

Latest News

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

Working with Edinburgh Genetics to produce COVID-19...

We recently announced our partnership with Edinburgh Genetics on a project to manufacture antibody test kits developed to support the...

Securing supply: resurgence of UK manufacturing

The flexibility, high profit margins and lower costs of manufacturing in the East make it an appealing base, but in...

COVID-19 Antibody test kits donated to Autism...

Following an antibody test which Autism Anglia’s Business Manager Ian Crighton took courtesy of Europlaz, Ian wanted to see if...