Development and production form the backbone for the success of the medical and pharmaceutical technology industry. Medical and pharmaceutical technology are highly innovative industries that work with short product cycles. Subsequently, successful project management, quality assurance and process optimisation all the more necessary.
The international competitiveness that characterises the medical technology industry for the national and international marketing of the highly-developed and complex products and solutions hinges on the best possible optimisation of the process chain and the ongoing development of optimisation strategies.
In recent years, the need for professional, individual project management in medical technology has grown and, thus, increasingly determines the success or failure of your company.
- Strong international differences in regulatory requirements for the approval and distribution of medical technology products,
- Decisive technology trends include digitalisation, the use of artificial intelligence, the robust development in sensor technology and individualised medical technology.
We support you in the following key areas:
- Project planning, monitoring and control, observance of specific stakeholder requirements with regard to data protection laws or medical device laws by means of cost and effort estimates (time, costs), the determination of resources, the verification of conformity with standards and the planning of risk management (as per the ISO industry standard 13485).
- We work hand in hand with quality management. As project managers, we plan and review quality assurance.
- We advise you on all technical questions regarding digitalisation, as well as on the use of AI and sensor systems.
- We have already gained significant experience in the application and implementation of regulatory affairs.