avasis has been serving customers in medical technology for many years. Based on the long experience of the team as well as the experience from various customer projects, a clear focus on this industry has been developed.
Industry-specific solutions for digitalization
Processes in medical technology are different from the processes in other industries. Medical technology manufacturers in particular have to face a variety of different challenges: Rising health care costs, regulatory requirements, and much more. Therefore, the avasis Medical Technology team focuses on the development and implementation of digital solutions for processes and documents that meet the industry-specific requirements in terms of laws, standards, and guidelines.
We support the stakeholders of the medical technology industry in the introduction and optimization of specialized software solutions for the core issues: Product development, risk management, usability, clinical evaluation, post-market clinical follow-up, post-market surveillance, software tool validation and other ISO 13485 processes.
Expertise in medical technology
Medical device companies benefit from the unique combination of our expertise in the following areas:
- Development of medical devices and preparation of technical documentation
- Implementation of legal requirements with focus on Europe (MDD/AIMD, MDR) and USA (21 CFR Part 820 and Part 11)
- Efficient implementation of standards and guidelines, in particular: ISO 14971, IEC 62304 / IEC 82304, IEC 62366-1, MEDDEV 2.7/1, and MDCG guidelines
- Detailed knowledge of ISO 13485 as well as lean implementation of required processes
- Comprehensive knowledge of the software platform Polarion as well as its configuration and expansion
- Agile software development and agile project management
- Risk-based validation of software tools according to ISO 13485, ISO 80002-2 as well as 21 CFR Part 11
Together with our collaboration partners and customers, we have developed inspiring solutions over the last few years: It allows you to work more efficiently and use your capacities for the development of innovative products.
