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.

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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.

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