Medical devices continuously grow in importance offering new inventions and advances in disease management. Today, medical devices offer life-saving and life-sustaining treatments, can be implantable or make decisions based on artificial intelligence approaches.
Such devices can cause serious, even fatal, injuries if they are not properly safeguarded – Functional Safety is of particular importance.
Engineering services, consulting or assessments from exida will ensure a proper development of medical devices incorporating common safety standards, such as IEC 61508, IEC 62304, Medical Device Regulation, ISO14971, IEC 60601 and FDA Guidelines.
Services and Training
exida‘s engineers are the undisputed experts in solving safety critical problems. Our services cover the full safety development lifecycle, from initial risk assessments to design, all the way to Functional Safety Assessments and Audits of newly completed or existing developments. We have the ability to solve complex issues and stand ready to assist when needed.
We supply trainings in the area of medical device development. In addition to regularly scheduled courses, we are also available to perform on-site customized trainings to suit your specific needs.
Independent verification and assessment
During the development lifecycle of a medical device, companies benefit from independent third party reviews, especially in situations where the complexity of safety concepts is high. In these situations, you can use exida as a part of your team to perform a validation of your development. Whether the purpose of the review is to ensure the compliance to a standard or to prepare a technical file for the FDA or notified bodies, exida can validate your systems against a wide variety of applicable standards and regulations.
Tools and Templates
Years of experience in safety related industry sectors have allowed us to crystallize our knowledge and convert it into the format that you need. exida has a wide variety of tools, templates and checklists available that can be adapted to your needs to support your development at best. This will speed up your developments but will also make them more thorough and compliant to standards.