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.
What is IEC 62366-1?
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. The usability engineering process i.a. Human factors engineering guides the manufacturer to identify, assess and mitigate usability risks associated with normal use i.a. correct use and possible use errors and gives the tools to control these risks. The standard is best used together with EC/TR 62366-2 since it provides background information on the methods and hands-on guidance on the implementation of the standard.
Together with Kasve you ensure that the usability of your medical device will be addressed in appropriate level in all of the product development phases and that the requirements of the standard will be fulfilled.
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.
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.