Making the design and development of medical devices simple for you - we work with you to understand your needs and to bring your vision to market.
We work with a range of customers, from emerging companies to established multinationals, delivering final medical devices or raw materials for your device.
Our manufacturing and laboratory are based in ISO13485 facilities with ISO class 7 cleanrooms in Germany.
Below are the consecutive stages that we follow for our co-development projects with partners. Each project is completely tailored to what you and your device need. It all starts with an idea, so reach out and let's discuss how we can turn your idea into a reality!
Define the goals of your unique project and design a bespoke development project to suit you
Prototype generation and review, fast feedback loops to define suitable manufacturing concepts for your desired product and the most effective packaging system.
Advancing the project from our laboratory to our production facility. Our Engineers scale up the process to meet your commercial demand.
All the verification and validation packages to prove product safety and efficacy. Cross functional teams work closely together to prepare the necessary information for the regulatory filing.
Supporting you in global regulatory submissions, our experienced Regulatory Affairs team has wide experience in global registrations.
Once the product is cleared in your desired regions then MedSkin Solutions will act as your contract manufacturer, manufacturing your unique product to satisfy your customer’s demand!
At MedSkin Solutions Dr. Suwelack we offer contract manufacturing services to manufacture your medical device.
Our facilities are ISO13485 certified, and we have clean room production facilities both of ISO clean room class 7 and 8.
We are MDSAP certified and sell medical devices made in our production facility across the world, including the USA, Europe and many Asia Pacific countries. Our facilities fulfil all FDA requirements and have been audited by several notified bodies and country authorities during the last years.
Some of the processes we have on site at our facility include industrial sized lyophilizers, mixing and milling technologies along with a modular coating system and a specialised converting centre, recently built in 2021 for converting and packaging.
Our approach to contract manufacturing your medical device usually follows one of two routes: