Quality Assurance and Regulatory Affairs
Quality assurance is at the core of business development. A quality management system helps newly-founded organisations prepare for growth and more established organisations to verify the efficiency of their processes and the repeatability of their operations.
Kasve participates in developing its clients’ quality management by contributing to building, updating, auditing and updating the system as a supporter and member or the organisation’s quality team. We have helped a number of medical device manufacturers, testing and clinical laboratories, and start-ups develop their operations.
Products categorised as medical devices need to obtain a CE marking to enter the European market. Kasve can help companies conform to the requirements set by legislation and standards, taking into account aspects such as the focus of business and the organisation’s size.
We also help organisations in preparing the necessary quality and risk management documentation and compile technical documentation for their product.
Two of Kasve’s quality specialists, Nina Vartiainen and Rosa Tengvall, also serve as framework agreement consultants of the ELY Centre Business Development Services. This means that the above services are also available at an affordable price as ELY Business Development (Kehpa) Day 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.
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.
Regulatory Affairs
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.
Do you need a qualified partner to support you?
We help healthtech companies succeed in the international market. Leverage our expertise and our comprehensive network!