Creating and maintaining technical documentation is the central requirement for the market access of medical devices. It serves as proof of compliance with regulatory requirements, such as the General Safety and Performance Requirements (GSPR) of the MDR. However, it is much more than just a formal obligation: it reduces liability risks and supports efficient product development as well as post-market surveillance (PMS).
Do you have questions about your technical documentation? We’d be happy to answer them during a first meeting – no strings attached!
Do you have questions about your technical documentation? We’d be happy to answer them during a first meeting – no strings attached!
What characterizes MDR-compliant technical documentation?
Complete and well-structured technical documentation is the foundation for a smooth conformity assessment. If certain requirements are not applicable to your product, you must provide a sound justification - ignoring them is not an option! The following aspects are essential for MDR-compliant technical documentation:- Consistency: Especially regarding the intended purpose and risk assessment,
- Structured product file: Well-organized, searchable, and traceable to regulatory requirements,
- Digital documentation: Minimization of redundancies and potentialsources of error,
- Comprehensive evidence: All product-related claims must be verifiable.
Our tip: Consider international requirements early on to leverage EU market access for approvals outside the EU as well.
Maintenance of technical documentation throughout the product lifecycle
Once a product file has been created, it must be continuously updated. This includes:
- Regular Updates: Integration of PMS data, including the Periodic Safety Update Report (PSUR) and risk management updates
- Change Management: Documentation of product modifications (e.g., component discontinuations)
- Optimization of Supporting Documentation: Adapting to current regulatory requirements
Our services for creating and maintaining technical documentation
- Creation & Structuring: Development of complete technical documentation in accordance with MDR, IVDR, and other regulatory requirements.
- Gap Analysis & Optimization: Review of existing documentation for completeness and compliance, identification of gaps, and actionable recommendations.
- Risk Management & Usability: Support in risk assessment, usability analysis, and documentation according to ISO 14971 and IEC 62366.
- Biological Evaluation & Clinical Evaluation: Creation and maintenance of biological evaluations (ISO 10993), and clinical evaluations (MDR Annex XIV).
- Validation & Verification: Documentation of test and verification results for software, sterility, biocompatibility, and electrical safety.
- Post-Market Surveillance (PMS): Development and implementation of PMS plans, preparation of PSURs & Post-Market Clinical Follow-up (PMCF) reports in accordance with MDR und IVDR.
- Lifecycle Management: Continuous maintenance and updating of documentation throughout the entire product lifecycle.
- Submission & Regulatory Communication: Assistance with submissions and regulatory communication with notified bodies and authorities.
- Digitalization & RIMS Integration (RIMS = Regulatory Information Management System): Consultation and implementation of digital solutions for efficient document management.
We can help you create, maintain, and optimize your technical documentation—customized, efficient, and always up to date with the latest regulatory requirements. Contact us!
