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

QAiRA is a cloud based SaaS for Medical Device -sector for monitoring regulations, tracking regulatory requirements and complying to the requirements. The service was created by medical device professionals from Kasve Ltd.

Health technology companies meet increased demands, due the Medical Device Regulation (MDR), to follow and ensure compliance to the regulations concerning companies and their products as well as changes in guidance and standards. With our service you can leave all this to us! At the moment, our database covers approximately 2000 key documents.

In addition, several easy-to-use checklists will be integrated to our service. The service will expedite the follow up of the compliance, product management and compilation of the technical documentation. Monitoring of the global product regulatory status will be easy.

QAiRA -Key Features

More information: www.qaira.io
Contact us: info@qaira.io