Quality Made Easy

Do you always struggle with the piles of paperwork that are inevitable when launching your Medical device or IVD product onto the market? QME can make these processes a great deal easier for you. We can show you the way through the labyrinth of legislation and directives that are applicable for design, development, production and sales of Medical Devices and IVD. Subsequently the implementation and maintenance of your ISO quality system, and compiling your documentation, will be much far less effortless. Once you have discovered that a well documented Quality Assurance system is not a burden, but a source of valuable information and a way of finance management, we have reached our goal, and work will consequently be more satisfying for you and your staff members. We have broad expertise and can offer the following services to our clients: Implementation and maintenance of ISO Quality Assurance systems in the field of Medical Devices and In Vitro Diagnostics Compiling of technical documentation for CE certification or FDA 520k filing of a Medical Device or IVD product. Performance of internal audits or audits at your critical suppliers Composing of user manuals Product training and product presentations Reporting and counselling at beta site studies. Lab technical hands-on and reporting Are you interested? Please contact us for an offer without engagement, or visit our website