Where Accuracy Meets Assurance
Validation is a critical stage of the medical device manufacturing process.
As a full service provider, we offer a range of stringent validation services, including factory acceptance testing (FAT) onsite, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).
On demand, we can provide full, detailed metrology reports, made possible with our top of the range equipment.
We can provide a range of validation options, depending on our customers requirements. We can validate newly built tools ahead of production or can also validate tools and production processes for product line transfers.
Having us perform some or all elements of the validation process can offer a variety of benefits including:
- We have an in-depth knowledge of design and functionality of the tool and can leverage on this expertise to ensure that the tool is installed correctly and operates optimally. Any changes needed can easily be carried out in our toolroom.
- We can streamline the qualification process, reducing the time and effort required from the customer. This can help to accelerate the overall timeline and speed up launch of the product.
- Leaving the validation process with us can free up internal resources.
While we have our own in-house validation processes, these can be tailored to customer requirements.
Our manufacturing process
At Lawrence Engineering, we provide a full range of services for clients seeking to source, design and manufacture medical tools and components. We cover all areas of the product lifecycle – from project concept and design, tool manufacture and metrology, through to full tool validation and cleanroom manufacturing.
Our design team at Lawrence Engineering collaborate closely with the customer to ensure that the tool meets their requirements. DFM is key at this stage to ensure the optimal design. We will provide customers with a detailed 3D CAD design of the product and tooling for approval. If required, the tool can be put through a moldflow analysis to stimulate the injection moulding process and outline any potential issues. At this stage there is also the option of a 3D printed proof of concept.
Once the design is confirmed we can begin with the manufacturing of either the prototype or production mould.
Factory Acceptance Test
Once the mould is made, if required, we can carry out a Factory Acceptance Test (FAT). This test confirms that the new tool complies with all contractual specifications.
If required by the customer, we can offer a range of validation services in house (IQ, OQ and PQ).
Once the tool is validated, we can move ahead with the production of parts using the new mould.
Elevate your medical device solutions with unmatched precision
Harness the unmatched precision and quality Lawrence Engineering provide to take your ideas to new heights. Partner with us to create medical device solutions that redefine excellence.