Services
Research
Research is the creativity of science and business.
Services for:
- Identification of new product concepts using multiple tools such as workshops, open innovation, IP landscape analysis, indirect benchmarking, Design To Cost and others depending on subject.
- Scouting of new technologies related to both manufacturing and quality control in production.
- Coordination and management of Research Projects.
- Advisory on IP strategy to maximize the value of the idea.
Design and Development
Creating a product requires a rigorous process.
Services for:
- Project Management of D&D Projects following the ISO 13485 standard with the possibility to use a complete set of forms developed by our team.
- Identification of a complete set of product specifications (Design Input) including regulatory and marketing requirements.
- Support for preparation of V&V plan as well as risk management documentation.
- Assessment of projects , pinpointing any gaps and feasible recovery actions.
- Business plan and marketing strategy for new products.
Quality and Regulatory
Continuous improvement to all aspects is our roadmap.
Services for:
- Assessment and gap analysis versus best practice or new standards, for example versus MDR. Preparation and execution of recovery plan.
- Support for quality system implementation in small biomedical companies or start-ups.
- Preparation of technical documentation for new medical devices, such as Design Control documents, Design History File or Technical File.
- Preliminary independent audits to get ready for certification audits.
Functional testing
Only what can be measured can be judged.
<Services for:
- Identification of testing plan in all phases of projects (during design or for V&V or for investigation)
- Possibility to execute functional tests at our lab, such as: tensile strength, torque force, burst, mechanical resistance at 40°C , material stress using temperature cycles (-70°C, + 180°C), dimensional measurement and test to simulate product usage.
- Collaboration with other labs for other tests.
- Possibility to perform functional test and to measure particle release due to product usage.
Training
People are the most important asset of a Company.
Services for:
- Customized training on medical device items: Design Control, MDR, R&D process, risk management and others.
- Training to increase company creativity and innovation level of the company with “learn & fun” methodology.
- “Design To Cost” course with application in Medical Device business.
- Project Management training delivered as classroom courses or as on-the-job training for young project managers.
- Tutoring activities for young engineers, technicians or managers.