Product compliance – or product conformity – is certainty that a product meets the regulatory requirements necessary to be available on the market.Companies bringing products on to the market fall under legal obligation to take the actions necessary to ensure product compliance.
For manufacturers across industries, product compliance is often the last step required before taking new technologies to market. Compliance support can be a long and complex process – but it doesn’t have to be. Our experts can provide you with testing services and regulatory guidance to ease the path to approval.
As one of the largest independent EMI and EMC testing companies in the US and the UK, we have years of experience testing products across industries. Our experts routinely provide support for medical device companies and are approved by a variety of national and international accrediting bodies.
The highest level of medical device test strategy takes the production testing of components, sub-assemblies, and the finished product into account for technical testing. Specific hardware and software requirements for each test stages are considered with the measurement methods and expected output in the test strategy.
In the validation process, the system is divided into small blocks without losing the traceability to the original test strategy and then the testing starts with specified requirements for each block in the system. Validation methods for each block are customized based on risk-based analysis for better fitting of the test strategy. The high-level test strategy provides a strong reference for technical reviews of the device and its validation.
We have experience throughout medical devices lifecycle stages, namely product ideation to design & development, component engineering, product re-engineering, testing and verification & validation, sustenance engineering, and regulatory compliances.