Furthermore, we are happy to support our early stage clients in any way we can with any regulatory submissions and all matters related to the product development lifecycle.
As a company, we have invested very substantially in our testing capability. Quality assurance is critical and there is no better way to control this than by arming our highly capable workforce with the apparatus to do the job thoroughly.
Test and Inspection Capabilities:
Contactless Dimensional Measurement – Our OGP CMM machines provide us with the ability to capture x, y and z dimensions via multi sensor measurements, maintaining the highest levels of accuracy. Data recording can be automated and SPC data generated to ensure optimum process quality levels are achieved.
Wettability and Coating Measurement – Whether it be contact angle and surface free energy of solids or surface tension of liquids, our Kruss system offers class leading performance, enabling us to quantify surface behaviour.
FlexMedical is committed to quality. We understand the need for statistical analysis and our black belt trained engineers use Minitab software to deliver assurance and continuously drive improvements.
To deliver customer requirements through using the ISO 13485:2016/ US Quality System Regulation, Quality Management System framework.
Employees work within the QMS and understand the impact of poor quality on our customers and our business.
Develop and implement quality processes that meet the needs of: –
- our customers
- our employees
- the requirements of ISO 13485:2016, 21 CFR 820, the In-vitro Diagnostic (IVDR) and Medical Device Directive / Regulation (MDR). (Formerly IVDD 98/79/EC, MDD 93/42/EEC)
Processes are, where required repeatable, measurable and monitored.
Products and Services are fit for purpose, measurable and monitored to meet the customer and regulatory requirements.
Establish and monitor measurable quality objectives and targets for the quality management system and processes.