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Evolving and Adapting: Medical Device Projects

Medical Device Project

Evolving and Adapting: Medical Device Projects

For over 40 years Europlaz has prototyped, manufactured and supported medical device advancement. From our initial development in the 1960s to pioneering advancements in modern medical applications; we have evolved our offering to provide the very best service for a wide range of clients from international blue-chip medical device suppliers to exciting start-up companies.

This experience is core to our service and ethos as we are constantly evolving and adapting to everchanging medical device industry needs. Here are just a few of the ways we have achieved this over recent years.

Medical device project improvements

Our heritage and success over several decades are in no small part due to our ability to evolve and adapt to changing environments. Our team carefully considers clients’ needs and looks for innovative ways to provide expert insight and undertake contract medical device manufacturing for exacting standards.

To highlight how we accommodate client demands and stay up to date with the latest developments we are going to focus on several key areas. These are;

  • Our cutting-edge facilities
  • Advanced metrology equipment
  • Bespoke sample kit assembly
  • Experienced and reliable third party logistics

These key areas provide a snapshot of just some of our services from ideation to culmination. At the same time highlighting a unified contract medical device manufacturing service that reduces costs and development time while simultaneously ensuring a higher standard of control and quality.

Cutting-edge facilities

Our facilities are crucial to our capabilities. The Europlaz site occupies 60,000 sq ft with state-of-the-art manufacturing facilities covering over 9,500 sq ft. Along with this, we have seven cleanrooms which are accredited to ISO 14644 Class 7 and are specifically designed for processing medical, diagnostic and drug delivery devices.

These facilities allow us to manufacture a wide range of medical devices from neonatal flow sensors to components used in kidney dialysis machines. We help clients develop products efficiently before rollout with cutting-edge medical prototyping to allow clients to cost and plan production effectively.

Our facilities provide advanced medical injection moulding capabilities, assembly, and packaging all controlled and monitored by our stringent quality assurance and control teams.

Our current injection moulding systems use the following machines:

  • Sumitomo (Electric): 35-100T
  • Krauss Maffei: 50-350T
  • Boy: 10T

Advanced metrology equipment

A key component of our medical product prototyping is ensuring measurements are accurate and consistent. To meet our clients’ demands, we offer a full metrology service capable of dimensional and performance assessments.

The regulations for medical devices require that where a device cannot be verified, for example where it is single use, the process of manufacturing must be validated.

The industry-standard approach to validation is through dimensional measurement of the component using a robust validation strategy, supported by accurate, consistent and trustworthy measurements. This provides a foundation to capability assessment, through a formula such as Pk or Cpk, which indicate process performance.

Europlaz’s Coordinate Measuring Machines measure with an accuracy down to 3 microns, or about 25 times smaller than the diameter of a human hair, and our automated testing equipment can simulate thousands of cycles of operation.

Our metrology services use calibrated equipment traceable to NIST standards and include:

  • Programmable Contact/Non-Contact Measurements
  • Force Testing
  • Pressure Testing
  • Analysis and Reporting
  • Capability Studies
  • Gauge R&R
  • First Article Inspection Reports

For more information on our processes or to get started on your medical device project please contact us today. Our team is on hand to provide more information on regulations, practises, and the Europlaz process.

Bespoke sample kit assembly

A recent service that we have invested heavily in is our medical test kit fulfilment offering. We understand that time and quality are core to fulfilling contract medical device manufacturing and as a result use semi-automated high throughput assembly lines to meet these needs.

This automated system is flexible and can be tailored to the specific needs of your medical device project from quickly scaling up production to reducing the risk of package contamination. Automation also means reduction in human error and thus can mean the difference between the success and failure of the device once it enters the market.

Here are just some of the benefits of our assembly:

  • Semi-automated work cells – increases the repeatability, productivity and safety of the assembly process.
  • Domestic and international shipping – B2C and B2B delivery available anywhere in the world.
  • Checkweigher – 100% check-weigh capabilities down to 0.1gram accuracy.
  • In-house automation expert knowledge – semi automated production lines with fully trained operatives.
  • Automatic barcode scanning and data uploads to third party software – ensures no order is forgotten.
  • Integrates with order fulfilment software – individual real time coding, labelling and scanning as required.
  • Test systems for 100% verification – auto rejection capabilities and test systems.
  • Real time stock inventory reporting and expiry date monitoring – all stock is stored in a temperature monitored warehouse.

Find out more about our comprehensive medical test kit assembly and fulfilment service available 24 hours a day, 7 days a week.

Experienced third-party logistics

Finally, as part of our comprehensive contract medical device project services, we will assist with your packaging, labelling and distribution. Our teams are experienced in moving products quickly and safely from development to distribution in our ISO 13485 certified QMS and FDA-compliant facility. By offering all these services under one roof, we can improve efficiency, reduce costs and provide a flexible third-party resource for development, production and logistics.

Our order fulfilment process involves:

  • Manufacturing – the product is manufactured in one of our Class 7 cleanrooms which are certified to ISO 14644 for airborne particulate.
  • Warehousing – after manufacture, the product is stored in our large warehouse. All goods are subject to strict inventory control.
  • Picking – once an order has been received, we pick and pack the order. All orders are traceable through our software. Packing slips and labels are attached to the shipment.
  • Shipping – once the order is ready to go, we will arrange the shipment. Due to our knowledge and experience, we have a preferred set of carriers with whom we partner with and have negotiated preferential rates. However we are happy to compare shipping costs from a variety of different carriers.

For more information about how we can assist with your medical device project

With over 50 years of experience, we have extensive knowledge and insight into the medical device design and manufacturing process. If you’re interested in finding out more about our services or want to know more about how we adapt solutions to your needs, please contact us now. We look forward to assisting you on your next medical device project.

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