With nearly 20 years of experience in medical device design and manufacture, OBS Medical has a large base of experience to assist other start-up companies in building a fully integrated and compliant Quality Management System that help support all aspects of business function, especially those necessary for CE Marking and launching new products.
Working with the client and understanding their needs, we can help create, install and train a QMS that supports their business processes and fulfils all the requirements of ISO 13485:2016 and the medical Device Directive (93/42/EEC) and new Medical Device Regulations (2017/745)
Using existing procedures and forms based on a wide knowledge base, it is possible to build a quality management system up within a short period of time and give training to employees on the business processes and how they can be run and maintained.
Employing a full time Quality Manager is often impractical and too expensive for a small company. OBS Medical can offer low cost resources and expertise for as long as required until your company has existing resource with sufficient understanding and abilities to drive and maintain the management system.
Dependent on location and business requirements, we offer a day rate, based on the frequency of consultancy.