Quality Management Systems in the Health Industry
A quality management system supports an organisation’s operations and also serves as evidence of the organisation’s commitment to a systematic approach to outsiders.
Build a superb QMS
Kasve provides services that meet clients’ needs for competence and resources that enable building a standardised quality management system. Kasve helps clients identify relevant legislation and standards, and collaborates with clients to design a quality management system that fulfils their needs. The resulting quality management system reflects the organisation and can be best incorporated into day-to-day operations.
We are ready to roll up our sleeves and collaborate with you to find the best way for your organisation to fulfil requirements and help you draw up different levels of documentation to guide operations and indicate conformity.
Update your QMS
Perhaps your organisation already has a quality management system you wish to update for the certification process or enable you to enter a new industry subject to new standard requirements. Kasve will assess what needs to be updated and prepare a plan that will allow you to meet your targets.
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.
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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 quality management systems for both medical device manufacturers and other organisations in the chain.
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
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.