Industrialisation
Industrialisation can be seen as a general term, but for us it explains the design, processes and documentation that must be carried out to get a product ready for manufacture.
What sets Shore apart is our multidisciplinary offering; as well as design and engineering, we provide clinical manufacture expertise and full production support.
We work collaboratively, both internally and with external stakeholders, to ensure that risk, cost, and quality are all considered. We apply different processes, technologies, and product volume options to produce bespoke solutions for our clients.
We work collaboratively, both internally and with external stakeholders, to ensure that risk, cost, and quality are all considered. We apply different processes, technologies, and product volume options to produce bespoke solutions for our clients.
Design Transfer
Working closely with the supply chain, we establish a process that can be fully validated, ensuring a full record of the project is detailed in the DHF, DMR and regulatory submissions.
Part & Process Qualification
We can support with documentation creation for each of the Installation Qualification, Operational Qualification and Performance Qualification phases to validate the manufacturing process. We can provide the evidence that your device operates according to requirements and performs safely to subsequently confirm that the manufacturing process can get underway.
Production Support
To de-risk the manufacturing process, we will advise on, and test whether, production tooling & parts are as per design intent, liaising directly with suppliers and manufacturers.
Clinical Manufacture & Supply
A key factor that sets us apart from many of our competitors is our ability to supply clients with components and complete devices for clinical trials. Here, the same exacting standards are applied in supply chain management, good manufacturing practice (GMP) and ISO 13485 compliance.
Production Fixture Design
Our engineers will design dedicated production-stage jigs and fixtures to ensure that products are assembled (or disassembled) efficiently, easily, reliably and repeatably.
QA Test Rigs
We help you to de-risk the production process, from concept development through verification testing to manufacture, via the design and engineering of bespoke test rigs.
View our medical product industrialisation capabilities in action:
