Your Single Solution for Medical Device Contract Manufacturing

It can be an arduous process, creating something from scratch. So: your business has an innovative new idea for a medical device – where do you start? As these questions begin to mount and you begin to do research, you can see that you actually need a handful of different specialised companies to create your products. Wouldn’t you rather have a single company that can assist you through the whole process? Because of our internal capabilities, we can offer end-to-end service with the design, manufacturing, and shipping of your medical devices – an innovative method in our industry that can save you time, complexity, and money. Our simple and transparent process can turn that inspired lightbulb moment into a real product in a few defined steps. Here we share the stages involved in our ‘end to end’ process. 1 – The process begins with design. PolarSeal uses the most advanced computer-aided design software paired with an innovative team of designers to bring you fast and accurate designs for whatever your needs. The fact that our designers are in-house and familiar with the materials, process, and capabilities ensures greater specificity and a more thorough understanding of how exactly your project will turn out. With extensive experience from diverse projects around the globe, we’re confident that our design team can create the solution you are looking for. 2 – Sometimes a design can only go so far, and before progressing to creating new biomedical products, a prototype is required. Our in-house laboratory and R&D department lead at this stage. Our R&D experts can quickly and efficiently produce prototypes to test and refine products before they go to market. Product efficiency and usefulness is key, especially in the medical device industry, so we encourage you to make use of our prototyping to suss out any issues that need fixing with your design. 3 – The next step in this process is choosing your materials – potentially the most important part of your product. How breathable does it need to be? How flexible? How sticky? For your product, second-best just isn’t going to cut it, so you can rely on our unrivalled stock of high-grade materials to get the job done. Medical device contract manufacturing is not a one-size-fits-all business, so we make sure we have a variety of different materials to suit the needs of your particular project. 4 – Design, research, material diversity… all of these are fundamentals of a successful product, but what about industry regulations? For devices that are used in a medical capacity, CE Marking is essential  in ensuring the highest industry standards of care in terms of health, safety, and the environment. Rest assured that we are fully accredited by the FDA and the European Notified Bodies, and audited regularly to make sure our processes meet the requirements. We have the capabilities to CE mark all your medical products. As far as the impact of Brexit goes, it is a fluid situation. However, we remain committed to bringing the highest-quality industry standard for medical devices used in Europe and abroad.