Developing a medical device or health technology software requires more than product development. It also takes regulatory expertise, a functioning quality system, systematic risk management and clinical evidence. Health technology consulting brings these areas of expertise in when they are not avai…
MDR Technical Documentation: What It Contains and How to Maintain It
Technical documentation is the material a manufacturer uses to demonstrate that a medical device meets the requirements of the MDR. Its structure is defined in MDR Annexes II and III, and the manufacturer must keep it up to date t…
Placing medical devices on the market and keeping them there is now about much more than technical documentation and a quality system. The EU Medical Device Regulation (MDR) has shifted the emphasis strongly toward clinical evaluation. Manufacturers must continuously demonstrate that their device is…
Clinipower is a partner organisation in the XiA – Xpanding Innovative Alliance -project and is helping to build European expertise in digital healthcare.
The XiA – project is launching its Community of Practice, a new European collaborative space designed to bring together professionals, educator…
Clinipower, together with Laurea University of Applied Sciences, is organizing an event in Finland as part of the European XiA (Xpanding Innovative Alliance) project. The event will examine the progress of the implementation of the European Health Data Space (EHDS) and its implications for Finnish o…
Usability Process: The Path to Safe Health Technology
The usability process in health technology development forms the foundation for safe and effective solutions. As medical devices and software become more deeply integrated into clinical work, their usability directly impacts patient safety and t…
The journey of health technology from innovation to market is a complex process that requires deep understanding of regulatory requirements, patient safety, and risk management. Product development in health technology differs significantly from other industries, as every stage from innovation to co…
The ISO 13485 standard specifies requirements for a quality management system (QMS) in organizations involved in the design, development, production, installation, and servicing of medical devices. It focuses on developing a robust QMS, comprehensive documentation, risk-based thinking, and continuou…
Internal auditing in accordance with ISO 13485 is a systematic and objective evaluation of how well an organization’s quality management system is functioning. It ensures compliance, identifies areas for improvement, and supports continuous improvement within a health technology company. The audit p…
