Validation
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.
Validation Process
We can validate our production processes to show that they can consistently produce a result or product meeting its predetermined specifications.
Our service includes both Process Validation and Test Method Validation.
Process Validation
Our process validation approach follows industry best practices and includes:
- IQ (Installation Qualification): Verifying that new or modified equipment is installed correctly.
- OQ (Operational Qualification): Verifying that a process produces parts within specification across its intended operational range.
- PQ (Performance Qualification): Demonstrating that the process consistently delivers results within specification under normal conditions.
- PFMEA (Process Failure Mode and Effects Analysis): We complete process Failure Mode and Effects Analysis to determine the criticality to quality of a product/ component’s characteristics
By statistically proving process capability through Statistical Process Control (SPC), we help reduce inspection volumes and streamline production – particularly beneficial in high-volume environments. We utilise Minitab, the industry-standard software, to carry out data analysis and capability studies as part of this process.
Test Method Validation (TMV)
We validate our test methods to ensure the accuracy and reliability of measurement and inspection (e.g measurement system or visual inspection standard).
TMV confirms that the measurement process consistently delivers valid results across multiple units
Our validation systems are designed to be lean and efficient, helping avoid unnecessary cost or waste while meeting all compliance requirements.
By managing the validation process in-house, we reduce the resource burden on your team, accelerate timelines, and ensure a smoother production start-up, all while leveraging our deep expertise in tool design and functionality.
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.
Tool Design
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.
Tool Manufacture
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. As part of this we complete a Capability Study. This shows that the process can produce parts that are “statistically in control”, giving the customer confidence that the process will pass their validation.
Validation
If required by the customer, we can offer a range of validation services in house (IQ, OQ and PQ).
Production
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.