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Frequently Asked Questions About Medical Devices

Frequently Asked Questions About Medical Devices

Over many years in the design and manufacture of disposable medical devices, the team at Meridian Medical has gathered a wealth of experience and knowledge about the different needs of customers and the wide range of products we have created.

In addition, new and existing customers often have questions about disposable medical devices and their design, manufacture and supply, which we are always more than happy to help answer.

Here are just a few of the questions that we regularly get asked, which might help answer your own queries about disposable medical devices:

What are disposable medical devices?

A disposable medical device is any medical product that is designed and intended to be used on one patient and then discarded after the completion of that treatment or a period of time.

They can be:

  • Individually packaged
  • Single use
  • Clinically clean / Non-sterile / Sterile
  • Typically used by trained physicians
  • Used in hospitals / GP surgeries and homes
  • Ideally low cost
  • Made in traceable batches
  • CE marked by a regulatory body

How long does it take to get typical medical equipment project from concept to point of sale?

Allowing about 12 months, including all regulatory submissions, is a good timeframe to work to.

If Meridian Medical is assembling the device, does that mean they are the manufacturer?

No, the manufacturer is always the company with legal responsibility for the product (the company holding the CE certificate). Meridian would be your supplier.

Can you provide the product under the Meridian CE mark?

Medical products will need to be manufactured using your own CE mark. We can introduce you to our preferred regulatory experts if you require additional expertise.

Can you manage all the suppliers, assembly, packaging and sterilisation?

Meridian Medical can supply complete end to end medical device manufacturing, as well as all subcontractor management.

Do parts that subcontractors supply need to be made in a cleanroom?

Ideally, yes, but depending on what the part is and its origin, cleaned can be ok.

Should I use EtO or Gamma for sterile medical devices?

This is always dependent on the medical device and its application. We would be happy to advise you on the best type of sterilisation for your product.

What is the difference between verification and validation?

Verification is checking each piece of medical equipment meets the specification, whereas validation is the process of proving the manufacturing process repeatedly produces the correct medical device.

Can you export to other countries?

Yes, Meridian Medical can export your medical device to any country using our approved logistics suppliers.

What are the key attributes to look for in a contract manufacturer of medical disposables?

Selecting a contractor to manufacture your medical device is an important decision. There are many key attributes that you should look for in a medical devices manufacturing partner, from the quality of their facilities and equipment, through to the range of services they offer and their approach to working with you.

Where can I get expert advice and guidance on getting a medical device manufactured?

The team at Meridian Medical is always happy to discuss the production of any kind of medical device and offers a comprehensive range of services to meet any or all of your needs.

Meridian Medical is as an established and experienced contract medical equipment manufacturer, specialising in a wide range of sterile and non sterile medical device design, development and supply.

To find out more about how Meridian Medical can help you with your disposable medical product design or manufacture, get in touch today by filling out our online form, calling our sales team on 01903 732344 or emailing info@meridian-medical.com.

Published 13/11/2018


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