As a manufacturer of medical devices, you are met with many requirements and comprehensive regulation when your medical devices are to be released on the market. Therefore, it is a determining factor that you begin the process correctly and consider legal requirements for product and quality management, from the beginning of the development phase.
Our medico team will assist you safely through the relevant legal requirements and standards for software and electronically intelligent products – from the concept phase to the marketing of your product as a medical device. This includes the following areas:
- Development of regulatory strategy, incl. requirement specification and requirements in relation to marketing
- CE marking of your product, including technical documentation and regulatory processes
- Building a quality management system (QMS) in accordance with ISO 13485
- Establishment of specific quality assurance processes
- GAP analysis in relation to new standards and new legal requirements
- Specific guidance, including document review, and updating of critical processes, e.g. in relation to ISO 13485 – quality management systems; ISO 14971 – risk management; IEC 62304 – Software for medical devices; IEC 82304-1 – Software systems for the healthcare services; and IEC 62366-1 – Usability design
- Courses in quality processes, software-related subjects, writing of requirements, etc.
- Internal audits.
Our guidance on the road to market access, provides you with a number of strategic advantages:
- A clear strategy for legal marketing
- Effective building up of your documentation for CE marking or other types of approval of your product
- Effective quality assurance processes that fulfil relevant regulatory requirements.
We have many years of experience within the medico industry. We have built up teams of specialists with expert knowledge within technical and regulatory requirements, quality management for medical devices, and test strategies. We also perform the accredited technical tests that are required in order to legally sell medical devices.
With FORCE Technology as your consultant in the preparation for market launch, you will get:
- Expert advice about legal requirements, approvals, tests, and quality management
- Access to specialist knowledge regarding apps and software for medical devices
- A qualifying, targeted development process for your product
- Access to the our knowledge about standards, via our active participation in standardisation working groups.
Hørsholm, Aarhus and at the client’s location
ISO 13485, ISO 14971, IEC 62304, IEC 82304-1,IEC 62366-1
We offer a one-stop-shop solution guiding you through all the necessary steps, from developing a new concept to launching your medical devices onto the market