Our experienced team has assisted several MedTech companies in developing design control documentation that brings value to the project and the product and is consistent across the entire documentation, including labelling. Design Control through a development project is about overview, experience with product development, planning and of course preparation of documentation at a necessary […]
When developing medical devices many challenges must be overcome but Design Control does not have to be one of them. Design control is a set of quality practices and procedures incorporated into the design and development process to control the design process and assure that device specifications meet user needs and intended use. […]
Identifying, estimating, and evaluating your device risks at the right time will increase the quality and safety of the device and can motivate the project members. Furthermore, it adds value by decreasing the project risks and avoiding costly late-stage changes. An effective Risk Management process is mandated by regulatory authorities (21 CFR 820 and 93/42/EEC […]
Design Input – agreeing on what to design Development projects are complex and often the team is not even in the same location. Writing unambiguous and specific design input requirements are of the utmost importance. According to a study that included large, medium, and small companies (incl. healthcare), opinions about why projects are impaired and […]