Medical device manufacturing requires a level of process control according to the classification of the device. These days, with the aid of CAD or modelling platforms, the work is now much faster, and this can act also as a tool for strategic design generation as well as a marketing tool.Failure to meet cost targets will lead to substantial losses for an organisation.Regulatory authorities recognize the critical nature of a sterile barrier system.In fact, they consider packaging an accessory or a component of the medical device, which implies that the package system is nearly as important as the device itself.QTS adheres to ISO standard 11607, “Packaging for Terminally Sterilized Medical Devices,” an international standard that specifies the requirements for single-use materials and re-usable containers for packaging of terminally sterilized medical devices.
We routinely execute many physical tests required by ISO 11607 on your sterile barrier packaging.
In addition, with global competition, the R&D of new devices is not just a necessity, it is an imperative for medical device manufacturers.
The realisation of a new design can be very costly, especially with the shorter product life cycle.
Product families are often established so that a representative product can be chosen to represent an entire product family for validation purposes.
This can considerably reduce the costs associated with a validation.
These standards help to identify characteristics such as chemical content, acidity or alkalinity, tensile breaking strength, peel adhesion, and water, oil, and tear resistance among others.