ISO 13485 -standard
The ISO 13485 standard sets a frame for a quality management system for medical devices.
What is ISO 13485?
The ISO 13485 standard sets a frame for a quality management system for medical devices. The standard focuses on the requirements that an organisation must meet to indicate that the medical device and the manufactures organization and other activities comply with the requirements of the relevant regulations and the clients needs. A certified, ISO 13485 standard compliant quality management system is a requirement – set by EU legislation (MDR, IVDR) for the manufacturers of IIa, IIb and III class devices.
Kasve’s specialists have been involved in developing, updating and auditing several quality management systems of medical device manufacturers to ensure compliance with the ISO 13485 standard. Kasve will support your organization in defining and developing your quality management system,, in identifying and describing the processes, development activities and auditing the completed quality management system. Kasve’s specialists are qualified to perform audits on ISO 13485 compliant organizations and activities (lead auditor and internal auditor qualitifications).
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.
Looking for a quality expert?
We have helped a number of medicinal device manufacturers, testing and clinical laboratories, and start-ups develop their operations.
See our references
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.
A comprehensive partner for the establishment phase
Kasve accompanied the preparation and establishment phase of Neurocenter Finland.
We gained industry and business expertise to establish a new type of cooperation entity
Kasve supported the establishment of Kuopio Health by acting as project manager of the establishment project and as temporary CEO in close cooperation with the University of Eastern Finland.
Additional drive to develop the startup business
Kasve has consulted Probitat in the development of a research-based startup business and i.a. in compiling sales and investor material.
Led by Kasve, a leap towards a modern smart city
Together with Kasve, City of Kuopio carried out a business cooperation study for the Data Refinery project.
We launched the product as planned
Together with Kasve, Adamant Health built a quality management system on time to enable them to apply for the CE mark for their medical device.
Kasve brought us enourmous Quality Management know-how
Together with Kasve, Kustannus Oy Duodecim has built a Quality Management System in accordance with the ISO 13485 standard, and is developing software product in accordance with the IEC 62304 standard.
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.