Outsourced Quality Manager
Kasve’s Outsourced Quality Manager and Person Responsible for Regulatory Compliance service enables your organisation to focus on its core competence.
Expert quality management
Kasve’s Outsourced Quality Manager and Person Responsible for Regulatory Compliance service enables your organisation to focus on its core competence. Use the service to gain access to an external expert or team of experts as part of your organisation to the extent you need at a given time. The outsourced Quality Manager will collaborate with your organisation’s leadership and under its mandate in managing your quality management system and ensuring its regulatory compliance.
Quality manager as a service
The legislation concerning medical devices requires that organisations (manufacturer and authorised representative) have access to a Person Responsible for Regulatory Compliance. However, this person does not necessarily have to be employed by your organisation; instead, you can outsource the service. Kasve has expertise and specialists ready to take on these tasks, for instance, until your organisation has had time to train an employee to take care of these responsibilities.
Environment for medical software development to Migrevention
Migrevention is a digital headache clinic solution for patients, specialists, and clinics to manage migraine and other primary headaches. Kasve implemented a project with Migrevention in which an environment was created for the development of medical software.
With the help of Kasve, we developed a marketable medical device in a year
Together with Kasve, Nursie Health built a quality management system for their mobile application, which is a medical device.
Growth requires a quality management system
Nordic Laboratories did a preliminary study with Kasve for the clinical laboratory's quality management system, and is now building the quality management system itself.
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Get to know the standards
IEC 60601 -standard
IEC 60601 is a series of technical standards that describes the requirements for the safety and essential performance of medical electrical equipment.
IEC 62304 -standard
IEC 62304 defines the set of processes for life-cycle management of medical device software.
ISO 13485 -standard
The ISO 13485 standard sets a frame for a quality management system for medical devices.
ISO 14971 -standard
ISO 14971 is a key risk management standard for medical device manufacturers.
ISO 15189 -standard
ISO 15189 is the quality management standard for medical / clinical laboratories, which places the patient care perspective at its centre.
ISO 17025 -standard
The ISO 17025 standard for testing and calibration laboratories describes the general and technical requirements for the competent, impartial and consistent operation of laboratories.
ISO 27001 -standard
ISO 27001 is an internationally well-known information security standard.
ISO 62366-1 -standard
IEC 62366-1:2015 describes the processes for a manufacturer of medical devices to analyse, specify, develop and evaluate the usability of the medical device as it relates to safety.
See more services
Environmental and occupational safety systems
Kasve can help companies to integrate the existing quality management system and the environmental and/or occupational safety system to be built into one functional management system.
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.
An efficient, easy-to-use and modern quality management system for a medical device manufacturer.
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.