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.…
Over the many years that Meridian Medical has been operating, we have learnt some valuable lessons when it comes to designing medical devices, from the initial concept and prototyping through to full-scale production. We believe that understanding some of the…
The need to manage infection risks and prevent cross-contamination in medical institutions requires stringent processes for the cleaning and reuse of equipment, all of which takes time, resources and often costly specialist equipment. This can add costs to budgets already…
The decision to outsource any part of your operation to a contractor is not one to be taken lightly. Involving other parties in what is essentially your business can seem like a daunting prospect. But do your research thoroughly, choose…