We love processes, procedures, and work instructions. If you feel differently, we have just the solution for you: our QMS Service\u2014for your quality management systems (QMS)<\/strong>. <\/p>\n We\u2019re here for you when it comes to laying the groundwork for your products. Our team of ISO 9001, MDSAP, and ISO 13485 experts will support you every step of the way. With thousands of processes to choose from, we know from experience what really matters. We\u2019ll get your quality management system (QMS)<\/strong> up and running for your company, your team, and your products. <\/p><\/p>\n<\/div><\/div><\/div><\/div><\/div> If the project to be implemented is a medical device as defined by the MDR, a quality management system (QMS)<\/strong> must be established and maintained. ISO 13485<\/strong> specifies the requirements for quality management systems for medical devices and serves as the basis for many manufacturers to implement regulatory requirements. Depending on the product, additional standards, such as IEC 62304<\/strong>, must also be taken into account. This standard defines the requirements for the software life cycle and covers, among other things, software engineering, software maintenance, software risk management, software configuration management, and the problem-solving process. Technical documentation is also an essential component of the quality management system. <\/p>\n<\/div><\/div><\/div><\/div><\/div> Implementation of New Quality Management Systems for ISO 9001, MDSAP, and ISO 13485<\/p>\n<\/header><\/div>\n<\/div><\/li> Maintaining and updating existing QMS<\/p>\n<\/header><\/header><\/div>\n<\/div><\/li> Gap analysis<\/p>\n<\/header><\/header><\/div>\n<\/div>\n<\/div><\/li> Preparation, implementation and follow-up of certification, supplier and internal audits<\/p>\n<\/header><\/header><\/div>\n<\/div>\n<\/div><\/li> Preparation and implementation of management review meetings<\/p>\n<\/header><\/header><\/div>\n<\/div>\n<\/div><\/li> CAPA handling<\/p>\n<\/header><\/header><\/div>\n<\/div>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div>QMS in accordance with the Medical Device Regulation (MDR)<\/h3><\/h3><\/div>
This is how we support you with your QMS<\/h3><\/h3><\/div>