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.
Teamcenter Medical Device Solution
For your product development, the PLM solution “Teamcenter Medical Device Solution” supports compliance with processes and facilitates submission management, which increases efficiency significantly.
Management of digital templates and electronic review and approval process.
Comprehensive solution for a risk management process according to ISO 14971 with interfaces to development, usability, and clinical evaluation.
Comprehensive reporting functions for planning and implementation of tests as well as the representation of dependencies between information elements
avaFMEA is an add-on for avaRisk and offers functionalities for the documentation of an FMEA.
Systematic execution and updating of clinical evaluation as well as integration of information from product development, risk management, and post-market surveillance.
Simplified literature search for clinical evaluations thanks to automatically executed and documented searches in PubMed and PubMed Central.
Efficient updating of the clinical evaluation: Preparation of PMCF Plan and PMCF Evaluation Report as well as monitoring of PMCF activities.
Efficient management of regulatory information & easy integration into product development
Are you interested in digital solutions that meet the requirements of your industry? Then get in touch with our experts. We will definitely find a specialized solution for you.