Kasve can help you at the different stages of regulatory management.
Meet market reguirements
It takes huge effort and diverse competence to launch a medicinal or In Vitro Diagnostic device to the market. We have built a network around the competence of our specialists, bringing together extensive knowledge in solving various regulatory challenges, whether you are seeking to obtain a CE marking or FDA approval.
Kasve can help you at the different stages of regulatory management. We also actively utilise our comprehensive networks to always provide you with the best possible expert to meet your specific challenge.
Broad expertise at your service
We can help you with tasks such as:
- Product classifications, defining purpose and mechanism
- CE marking and FDA approval
- Biocompatibility surveys
- Use instructions and markings
- Risk management
- Required tests and trials
- Usability planning and tests
- Clinical assessment plan
- Clinical validations for in-vitro diagnostics
- Selecting and communicating with a Notified Body
- Competitive tendering and validation of different vendors
Credibility for a Start-up with a QMS Certificate
Kasve supported Buddy Healthcare in building up the EN ISO 13485 compliant Quality Management System and developed company's internal auditing further.
Etsimo: ISO 13485:2016 Quality Management System
Team Kasve built up together with Etsimo key personnel an ISO 13485:2016 QMS that, for example, enhances the company’s R&D activities, risk management and training of personnel.
Cerenion: ISO 13485:2016 Quality Management System
Kasve helped to build up ISO 13485:2016 QMS that, for example, enhances company’s R&D activities, risk management and training of personnel. Kasve also participated into software development documentation.
Do you need a qualified partner to support you?
We help healthtech companies succeed in the international market. Leverage our expertise and our comprehensive network!
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Quality Management Systems in the Health Industry
Kasve will help you build a quality management system that suits your organisation’s operations and supports your business in the optimal way.
Software Development Tools
A turnkey solution for project and knowledge management in medical software product development. The Medical Device Project Management Kit is based on widely used tools.
Outsourced Software Development Project Manager
Kasve’s Software Development Project Manager ensures that your software development is proceeding with a goal-oriented and systematic approach.
Product Development Health Check
The Product Development Health Check will ensure that your product development project is appropriate and fulfils requirements.
IEC/EN 62304 Workshops and Training
The workshop involves presenting the main features of the product development of medical software and the IEC/EN 62304 standard to the extent that corresponds to the client’s needs.
With us, you will gain access to highly experienced specialists in regulatory affairs and their competence related to various regulatory challenges, such as obtaining a CE marking or FDA approval.
Outsourced Quality Manager
Using an outsourced Quality Manager or a person responsible for regulatory compliance will provide more flexibility and free your organisation’s resources to its core activities.
Quality Management System Audits and Evaluations
Kasve’s service range includes internal audits which help you conform to a specific standard, and evaluations and plans that enable you to update your system to meet new requirements.
Outsourced Business Development Manager
Kasve enables its clients to prepare for entering the international market or expand their activities without a need to commit to permanent staff. Kasve’s clients gain access to a highly experienced specialist for the time and extent you need.