Medical device labelling is a critical part of the medical device manufacturing process. Accurate labelling of medical devices is vital to ensuring market access, and the safe and proper use of medical devices by patients and care givers. Labelling is…
The relationship between customer and supplier is vitally important. As a medical device company it is crucial to your success that the relationship with your contract manufacturer not only works well, but is a true partnership. Whether you outsource medical…
Outsourcing product assembly is a strategic business decision being made by more and more medical device manufacturers, as they seek to better manage manufacturing costs and focus more on innovation. Faced with a spike in product demand but insufficient production…
The operation of advanced cleanroom facilities is a crucial component of the medical device assembly process and has a critical role in ensuring the quality, safety and success of medical devices. If disposable medical devices are not assembled in the…
Outsourcing product assembly is an increasingly popular strategy for medical device manufacturers that want to focus more on innovation and reduce manufacturing costs. The right contract partner will ensure that transferring product assembly is straightforward. Selecting a contract manufacturer of…
Quality Assurance should not be a unique selling point of a company involved in the manufacture and supply of disposable medical devices. A standard requirement of a company should be that the smallest detail matters. Everything should be perfect. The…
Quality assurance is critical to all medical devices, including disposable ones. Should a manufacturer fail to provide quality assurance and a product does not function correctly, it could have increased risk to the end user. A failure to assure quality…
Traceability is a crucial part of the medical device manufacturing process and plays a critical role in ensuring product quality and safety. The contract medical device manufacturer that you use should operate a comprehensive traceability framework. The function of a…
The most regulated industries are those which have the deepest impact on people’s lives and the potential to cause the most harm. It’s no surprise then to find healthcare at the top of the list of the most regulated industries.…
When designing a medical device it is always important to bear in mind that there are ultimately two end-users. The first end user is the medical staff member, who will be using the device to administer treatment to a patient.…