Health Tech Cluster Switzerland

Below, Bruno Gretler, Head of Regulatory at Congenius AG, explores the challenges of maintaining your technical documentation and some practical advice for optimisation.

The challenges of maintaining technical documentation

Medical device regulations are continually evolving, requiring manufacturers to regularly update their technical documentation to remain compliant. This process can be especially demanding for companies operating in multiple markets, as each region may have slightly different requirements. For instance, the implementation of the EU MDR has made clinical evaluation and risk management documentation more challenging, while both MDR and IVDR have increased the demands for Post-Market Surveillance, which many organisations find difficult to meet.

Furthermore, technical documentation encompasses a wide range of data from various sources. This information, generated throughout the product lifecycle, must be organised in a way that is accessible and consistent for global regulators. Managing such large and diverse datasets is challenging, particularly when regional differences in documentation standards can lead to redundancies and inefficiencies.

Departmental silos can also be problematic – with miscommunication or lack of alignment between departments potentially causing inconsistencies, jeopardising compliance and delaying market access.

Given the sensitive nature of technical documentation, robust cybersecurity is vital. With increasing threats, manufacturers must implement encryption, access controls, and regular audits to protect proprietary information, especially in shared or cloud-based systems. Effective implementation requires specialist expertise, which can be both costly, and tough to source.

Tailoring documentation to meet the unique regulatory expectations of each market also poses a challenge by increasing complexity and inconsistency risk. The choice between referencing source documents and copying content depends on your organisational structure and workflows, making it crucial to select the most efficient and user-friendly approach.

How to optimise your technical documentation

One of the most transformative shifts an organisation can make is moving from a document-centric mindset to thinking in terms of data sets. Transitioning from traditional document-based processes to a data-driven approach for managing information – and ultimately creating TD – unlocks unparalleled benefits. The medical devices industry is increasingly adopting specialised tools that mirror Model-Based Systems Engineering (MBSE) principles, bringing robust data-driven information management tailored to its unique needs. By connecting diverse organisational units involved in pre- and post-market processes, these systems facilitate seamless data sharing, enhance compliance, and drive innovation.

Adopting a hybrid approach to TD that references dynamic or frequently updated content while embedding static, critical information can help manufacturers balance regulatory compliance and operational efficiency, and applying automated change management can further reinforce your regulatory team’s productivity.

Creating modular documentation, which involves producing documentation in self-contained sections or “modules” that can be easily updated and reused, can prove efficient and beneficial for global compliance. Developing harmonised templates for TD and a global regulatory strategy that identifies shared documentation requirements across markets can also reduce duplicated effort.

Utilising robust, future-proof data or document management systems and aligning with international frameworks such as the IMDRF ToC can further streamline processes, whilst encouraging cross-departmental collaboration between R&D, regulatory affairs, quality assurance, and manufacturing teams through integrated document reviews and centralised communication channels is essential.

The digital transformation of documentation processes is revolutionising how manufacturers manage and maintain records. Cloud-based systems and AI-powered tools provide scalable, efficient, and secure solutions, enabling organisations to tailor their documentation for emerging technologies.

And last but not least, it’s crucial to foster continuous improvement by proactively implementing periodic reviews and audits to ensure your TD remains compliant and up to date with the latest regulatory requirements.   

Turning challenges into strategic opportunities

Managing technical documentation for medical devices and IVDs has evolved into a sophisticated balancing act.

The key lies in transforming TD from a reactive, compliance-driven burden into a proactive, strategic asset. When implemented effectively, optimised documentation systems reduce time to market, improve collaboration, and simplify global regulatory submissions, enabling manufacturers to focus on what truly matters: delivering safe, effective, and innovative medical devices.

As the medical device industry continues to evolve, those who invest in forward-thinking documentation practices today will be best positioned to lead tomorrow. Whether your organisation is just beginning its journey or has already embraced modern tools and workflows, the path to excellence lies in continuous improvement, scalability, and a commitment to innovation.

Should you have a challenge related to technical documentation, the regulatory consultants at Congenius AG are ready to help. Simply get in touch here to start the conversation.