We take an agile and risk-based approach to product development. By identifying and tackling the biggest risks first, we prove the technology through a combination of design, analysis, prototyping and testing.
Once the bigger technological risks have been resolved, we bring the full product together in a series of prototypes to validate internal stakeholder acceptance, user and customer acceptance, and test key regulatory approvals.
We support our clients through verification and validation processes to ensure the products meet the regulation required, whether UKCA, or CE mark, MDR/IVDR, FDA, UL, FCC approvals or industry specific regulations.
Consideration of how, where and by whom the product is going to be manufactured is key throughout the product development process, as are the needs of the end user and related stakeholders like service engineers. Design for Manufacture, Service, Cost, Reliability, Quality and other related attributes (collectively known as Design for Excellence or DfX) are implemented throughout the process.
To enable a successful conclusion to product development, handover to the manufacturer (either our client’s team or a third party) is essential, so we ensure documentation is up to the highest of standards and our team is available to support the manufacturer in all aspects of ramping up to full production volumes.
Our processes are certified to ISO 9001, and ISO 13485 for medical device development.