Organizations should update their health technology standards processes regularly, especially when regulations change, based on audit findings, or as technology evolves. Significant regulatory changes like the MDR regulation require immediate action, while routine evaluation should be conducted at least annually.
Why is regular updating of health technology standards processes critical?
Health technology regulation is constantly evolving, and organizations must keep pace with changes to maintain their market authorization and ensure patient safety. The implementation of the MDR regulation (EU 2017/745) is a good example of how significant regulatory changes affect the entire industry.
Operating with outdated processes can lead to serious consequences. Loss of CE marking, market withdrawal, or patient safety risks are all possible outcomes if an organization fails to keep up with regulatory developments.
Regular process updating also brings competitive advantage. Organizations that anticipate regulatory changes and update their processes in time can bring products to market faster than their competitors. Additionally, up-to-date processes enhance the organization’s credibility in the eyes of customers and partners.
What signs indicate that an organization’s standard processes need updating?
Several warning signs may appear when an organization’s processes begin to become outdated. The first sign is often non-conformities identified in audits or inspections, which indicate process inadequacy in meeting current requirements.
Regulatory changes are another clear indicator. When new standards are published or existing ones are updated, the organization should assess their impact on its own processes. For example, updates to the ISO 13485 standard or new IEC 62304 requirements for software development may require significant process changes.
Technological development also creates a need for process updates. Digitalization brings new challenges to risk management and quality systems. Organizations must ensure that their processes also cover these new technologies.
How often should health technology standard processes be evaluated and updated?
The recommended evaluation interval depends on the organization’s size, scope of operations, and product complexity. Large organizations benefit from continuous monitoring and annual reviews, while smaller companies can implement more thorough evaluations every 12-18 months.
Startup companies need special support in building and maintaining processes. They should first focus on creating the most critical processes and gradually expand their system as the business grows.
Internationally operating organizations face additional challenges, as requirements in different markets may differ from each other. For example, FDA requirements in the United States differ from EU regulation, which requires adapting processes to different market areas.
Developing organizational culture is as important as updating technical processes. Staff training and commitment to new processes ensures that changes are actually implemented in practice.
Regular updating of health technology standards processes is not just a regulatory requirement, but a strategic competitive advantage. Organizations that invest in continuous development of their processes can respond more quickly to market changes and bring innovative products safely to market.
Related Articles
- What are the most important health technology standards?
- What are the key requirements of the ISO 13485 standard in health technology?
- How to start implementing health technology standards in an organization?
- How to start planning internal auditing?
- IEC 62304 standard requirements in medical software development
