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
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.
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.
Blueprint Genetics: ISO 15189 – Quality Management System for clinical research laboratory
Team Kasve was responsible for building up a QMS to match ISO 15189 and US CLIA, Clinical Laboratory Improvement Amendments, requirements, and worked as an outsourced quality manager.