Health technology companies can ensure compliance with health technology standards by building a comprehensive quality management system, implementing risk management processes, and ensuring regular staff training. Standards compliance also requires systematic documentation and continuous monitoring throughout the entire product lifecycle.
Why is compliance with health technology standards critical for companies?
Compliance with health technology standards is critical for companies primarily to ensure patient safety. Standards create a unified framework that guarantees product safety and effectiveness in all use situations.
From a business continuity perspective, standards compliance enables CE marking and access to international markets. Without proper standards compliance, a company cannot commercialize its products in healthcare markets.
The regulatory environment sets strict requirements for health technology companies. The Medical Device Regulation MDR and other regulations require a systematic approach to quality and safety. Failure to comply with standards can lead to significant financial consequences and loss of market position.
What standards should a health technology company comply with?
The most essential health technology standards cover quality management, risk management, and software development requirements. The ISO 13485 standard defines quality management system requirements for medical device manufacturers.
The ISO 14971 standard focuses on risk management and covers hazard identification, risk analysis, and risk reduction measures. This standard is an essential part of the entire lifecycle of medical devices.
The IEC 62304 standard addresses medical software lifecycle processes, including development, maintenance, and configuration management. In software development, this standard ensures regulatory-compliant documentation.
The Medical Device Regulation MDR (EU 2017/745) sets its own requirements for product safety and performance. The usability standard IEC 62366, in turn, ensures safe use of products from the end-user perspective.
How can a company practically ensure standards compliance?
In practice, standards compliance begins with building a quality system tailored to the organization’s needs. An ISO 13485-compliant system can be built in a customized manner for both large organizations and startup companies.
Risk management processes must be integrated as part of product development from the beginning. This includes identifying hazardous situations, risk analysis, and planning and implementing reduction measures in accordance with the ISO 14971 standard.
Documentation management is a central part of standards compliance. All processes, decisions, and actions must be documented according to regulatory requirements. In software development, the IEC 62304 standard defines the required scope of documentation.
Staff training ensures that all organization members understand standards requirements and know how to act in accordance with them. Regular training and updates are essential due to regulatory changes.
Key takeaways for health technology standards management
Health technology standards management requires a systematic approach and long-term commitment. Standards compliance is not a one-time project, but a continuous process that runs through the entire product lifecycle.
Successful standards implementation requires developing the organization’s operational culture and engaging all stakeholders. Industry requirements must be considered already in the early stages of product development to avoid later costs and delays.
Utilizing expert assistance in standards implementation can significantly accelerate the process and ensure compliance with requirements. An experienced partner can guide the organization in the right direction and help avoid typical pitfalls in the health technology regulatory environment.
