Assessment of need for CE registration is tightly bound with medical devices. Kasve is a seasoned operator when it comes to assessing the risk class of a product to be CE-marked and to creating the documentation needed for the CE registration.

Our quality and registration services for health technology companies:

• Pre-evaluation of company operations and compilation of action plan for quality management system build-up
• Building up ISO 13485 -compliant quality management system
• Creating documents related to CE registration, such as the technical file, risk assessment and design dossier
• Assessment of need for pre-clinical, clinical and safety information
• Definition of product classification, intended purpose and mode of action
• Notified Body selection and communication
• Internal and subcontractor audits
• Trainings related to medical devices
• Outsourced Quality Manager

“The State of the Art” way of describing medical device software and their documentation is standard IEC/EN 62304, medical device software development life cycle. We have helped several of our clients by assessing quality and documentation needs for a standalone software,  fulfilling the requirements and building the needed documentation/process framework and documentation for the medical device software.

Our services for medical device software companies:

• Is your software product medical device or not?
• IEC/EN 62304 workshop
  • Software safety classification
  • Software architectural description
  • Detailed design
  • Software tools as part of software development
  • R&D and agile methodology
  • Risk management
  • Documentation

Team Kasve’s versatile expertise in medical device domain and global networks are at your disposal.

Our business development services for health technology companies:

• Searching and contacting distributor and marketing partners
• International market researches and market potential evaluation
• Negotiations and contract drafts
• Strategy work: planning of growth and international business
• Portfolio expansions to international markets
• Outsourced Business Development Manager

Team Kasve has successfully helped several medical device manufacturers by finding partners, applying/acquiring funding and managing projects.

Our R&D services to health technology companies:

• Selection of the best R&D partners and evaluation of research needs
• Evaluation of research needs and planning, managing and coordinating research studies
• Compilation and inspection of research and validation plans
• Preparing of R&D project as well as compilation of project plans and funding applications
• Outsourced Project Manager