Frequently asked questions about contract medical device manufacturing

Yes, we can export your medical device to any country using our approved logistics suppliers. Our sales price excludes delivery and any taxes applied, so this will need to be calculated when placing the order.

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

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.

All cleanroom production areas are regularly validated to ensure they meet customers’ strict standards and are routinely and rigorously inspected by the microbiological team to ensure they meet the required levels of product cleanliness.

Each of the purpose-built Class 7 assembly cleanrooms has different capabilities. For example, one cleanroom houses a 10kw digitally programmable double-shuttle RF welder, while another features UV curing and bonding equipment and ultrasonic welding machines.

A third cleanroom houses programmable drilling machinery, pad printing and tube forming equipment to produce catheters and fluid lines.

The fourth cleanroom houses custom-built robotic dipping and rotary inspection equipment.

Ideally, yes, but depending on what the part is and its origin, having it cleaned can be acceptable, too.

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.

The vast majority of designs can be 3D printed or prototyped, however, mass production via injection moulding has its limitations. We can advise and assist you with any required design for manufacture.

We regularly support customers in more complex processes, such as high processing temperatures or significant drying requirements, by preparing for them at the beginning of the project using modelling software or prototype tooling. Unfortunately we do not have the equipment for twin shot or silicone injection moulding.

We have the latest certification to ISO9001 and ISO13485, and FDA registration for customers who plan to export to US markets.

We internally audit our production facility using rigorous cleanroom facility inspection, testing and validation systems.

We are happy to provide production costs for any run size.

Typically this is not an option. We find the working relationship is much cleaner when the customer owns their own tooling.

We can become involved with your project at any stage and will work closely with you to advise the best ways of progressing your ideas, designs or existing product(s) through our manufacturing processes.

By working with a contract medical equipment producer that offers an end-to-end service, you will have access to a level of service that in-house facilities or a multi-supplier set-up cannot match. Get more details.

There are a number of ways that the right medical device contract manufacturer should be able to assist with product development, helping to ensure the highest levels of product quality, strict scheduling and optimum manufacturing process cost-efficiency. Discover what they are.

Depending on what stage your product is within the design cycle and what class of device it is, typical times to reach point of sale can be 1 year onwards.

All products are tested and inspected and all onsite test equipment is calibrated and traceable to national and international standards.Our quality system complies with all the latest European and FDA standards, including ISO 13485, ISO 9001 and ISO 14001. Find out more.

Meridian Medical is a living wage employer and is committed to the policy of ethical trading by identifying and promoting good practice in the implementation of codes of labour practice. We promote the observance of internationally recognised labour standards, in particular fundamental human rights both for our employees and throughout global supply chains.

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.