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