Technical documentation
Structured technical documentation in accordance with regulatory requirements
Developing and maintaining technical documentation involves managing complex regulatory requirements and ensuring that the documentation is clear, complete, and ready for review. We help organizations establish structure, traceability, and compliance throughout the product’s entire lifecycle.
Challenges
Common challenges
Complex requirements and high standards for structure and traceability
Working with technical documentation involves managing complex regulatory requirements and ensuring that the documentation is accurate, complete, and up-to-date over time. Challenges often arise from the interplay between regulations, product definitions, and traceability requirements throughout the entire lifecycle.
Handling of Transitions for Existing Products Under Previous Regulations
Implementation of Robust Risk Management
Ensure proper labeling and IFU documentation
Handling Feedback from Notified Bodies and the FDA
Change Management and Impact Assessments
Integration of Software-Related Documentation Requirements
Managing Suppliers and Subcontractors from a Compliance Perspective
Preparing for Audits and Inspections
Maintenance of documentation throughout the entire lifecycle
We Offer
Operations-Oriented Technical Documentation
From Requirements to Lifecycle Management
We tailor our approach to the organization’s needs and ensure that technical documentation is structured, traceable, and tailored to the product, risk class, and market. With a pragmatic approach, we focus on creating documentation that meets regulatory requirements without unnecessary complexity. Throughout the product’s entire lifecycle—from development and classification to regulatory submissions, audits, and aftermarket support—we contribute to clarity, efficiency, and documentation that stands up to scrutiny.Regulatory Requirements and Strategy
Support regarding regulatory requirements, including the MDR, IVDR, and FDA regulations, as well as how these are applied in practice. We also provide support for regulatory strategies and global submissions.
Technical documentation
Support in structuring, creating, and maintaining technical documentation that is clear, complete, and ready for review.
Classification and Intended Use
Assistance in defining intended use and ensuring proper classification in accordance with regulatory requirements.
Clinical Evaluation and Performance Data
Support in ensuring sufficient clinical evidence and performance data in accordance with applicable regulations.
Risk Management and Quality Systems
Support for risk management in accordance with ISO 14971, as well as work with quality management systems and change management.
Audits, Dialogue with Regulatory Authorities, and Aftermarket
Support for audits and inspections, handling feedback from regulatory authorities, and work related to after-sales service, labeling, and instructions for use.
Value We Create
Customized and pragmatic solutions
Proven expertise in MDR, IVDR, and FDA
The right level of documentation without being overly complex
Support Throughout the Product's Lifecycle
Shorter time-to-market
Enhanced internal expertise and autonomy
Experience with medical devices in various risk classes
A risk-based and business-oriented approach
Customer cases
Here's How We Overcame Past Challenges
AI Diagnostics Ready to Meet Regulatory Requirements
Problem: AI-based software for cancer diagnostics was developed, but the requirements of the IVDR and the FDA created significant complexity regarding validation, documentation, and regulatory strategy. At the same time, there was a lack of tailored processes for secure and traceable AI development.
Solution: We established standardized development processes for AI and ML and developed a regulatory strategy for both CE marking and the FDA. This work included updating technical documentation and initiating early dialogue with the FDA through the Pre-Submission process.
Results: A regulatory-driven development process enabled a faster path to market approval in several regions. The client gained a robust foundation for validation, improved the quality of its documentation, and gained greater confidence in its interactions with regulatory authorities.
Regulatory Requirements and Strategy
Support regarding regulatory requirements, including the MDR, IVDR, and FDA regulations, as well as how these are applied in practice. We also provide support for regulatory strategies and global submissions.
Technical documentation
Support in structuring, creating, and maintaining technical documentation that is clear, complete, and ready for review.
Classification and Intended Use
Assistance in defining intended use and ensuring proper classification in accordance with regulatory requirements.
Clinical Evaluation and Performance Data
Support in ensuring sufficient clinical evidence and performance data in accordance with applicable regulations.
Risk Management and Quality Systems
Support for risk management in accordance with ISO 14971, as well as work with quality management systems and change management.
Audits, Dialogue with Regulatory Authorities, and Aftermarket
Support for audits and inspections, handling feedback from regulatory authorities, and work related to after-sales service, labeling, and instructions for use.
Common challenges
-> Handling of transitions for existing products in accordance with previous regulations
-> Implementation of robust risk management
-> Ensure proper labeling and IFU documentation
-> Handling feedback from notified bodies and the FDA
-> Change Management and Impact Assessments
-> Integration of software-related documentation requirements
-> Managing suppliers and subcontractors from a compliance perspective
-> Preparing for Audits and Inspections
-> Maintenance of documentation throughout the entire lifecycle
Features and benefits
-> Customized and pragmatic solutions
-> Proven expertise in MDR, IVDR, and FDA
-> The right level of documentation without being overly complex
-> Support throughout the product's entire life cycle
-> Shorter time-to-market
-> Enhanced internal expertise and autonomy
-> Experience with medical devices in various risk classes
-> A risk-based and business-oriented approach
CONTACT
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