Our service

Start-ups and companies that want to enter the medical technology sector easily underestimate the effort required by standards and laws. Therefore, it is important to deal with the standards and regulations already during the planning phase in order to avoid unexpected hurdles later on. Anyone who has ever read standards and laws knows that they are not easy to understand and leave a lot of room for interpretation. This is where we can provide support and "translate" the requirements in order to be able to implement them in the real world. The MDR requires medical device manufacturers in all cases to demonstrate an effective quality management system as a prerequisite for the authorisation and placing a product on the market in the EU. This includes above all the introduction of an effective risk management system. Medical device manufacturers must define the processes within the company and document them in procedural instructions. In a so-called "QM manual", quality policy, role descriptions, activities and their interrelationships are regulated.
Quality management should primarily serve as a guide for the company and its employees in their daily work. Unclear or non-existent procedural instructions reduce efficiency because employees have to think about the procedures over and over again, or because the work is repeatedly done in different ways. It is very easy to regulate either too little or too much. Both can disrupt daily work immensely.




We can support you with all these issues!

Organisation

  • Introduction of a quality management system as the basis for all activities of a manufacturer of medical devices
  • Creation, implementation and optimisation of QM processes
  • Establishment of the risk management and usability process in the company

Project Management

  • Preparation of the project plan
  • Risk assessment and monitoring of critical work packages
  • Ongoing monitoring and controlling of resources, time and budget
  • Corrections of the project plan in case of deviations

Planning

  • Capturing the legal requirements for medical devices
  • Presentation of the interrelationships of the applicable standards with the aid of checklists
  • Assistance with the precise definition of requirements

Development

  • Analysis and solution proposals for technical hurdles
  • Orientation of the development towards manufacturability
  • Preparation of the development file
  • Preparation of the design transfer file for production
  • Preparation of technical file
  • Creation of the service concept

Production & Post Market

  • Assistance with the selection of suppliers
  • Analysis of customer feedback
  • Optimisation of the maintenance/service process
  • Implementation of CAPA processes
  • Optimisation of the production process