In the highly regulated world of medical devices, comprehensive technical documentation is indispensable. It not only assures regulatory compliance but also underpins product safety, functionality, and continuous innovation. Drawing from NSF's extensive experience working with a diverse range of clients, NSF has identified and addressed some of the most pressing issues faced by manufacturers today. This white paper shares our insights into these challenges and provides guidance on how to mitigate them, based on real-world applications and solutions.
The top 5 technical documentation challenges
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Lack of cybersecurity documentation
Observation: Data breaches and cybersecurity incidents are becoming increasingly common, yet many manufacturers lack the necessary documentation to meet current standards such as the IEC 81001-series and guidelines from NIST. NSF's clients often face challenges in identifying and documenting cybersecurity-relevant data.
Guidance: Manufacturers should implement a comprehensive cybersecurity strategy that includes regular updates and maintenance plans. This proactive approach helps protect sensitive information and ensures regulatory compliance. Based on NSF's experience, a tailored cybersecurity plan addresses specific vulnerabilities and aligns with the latest industry standards, safeguarding both patient data and device functionality.
- Non-compliance with ISO 14971 risk management documentation
Observation: Risk management is a cornerstone of the medical device industry, but many organisations struggle to align their documentation with the latest ISO 14971 standard, published in 2019. Through NSF's work with various clients, we have seen common gaps in risk management processes and documentation.
Guidance: Regularly review and update risk management documentation to ensure it complies with the current state-of-the-art. Integrate risk management process interfaces with design & development, usability engineering, clinical evaluation or biological evaluation and other critical procedures. NSF's approach includes comprehensive reviews and individual updates, leveraging our deep industry knowledge to mitigate potential risks throughout the product lifecycle. Ensuring that risk management documentation is thorough and reflective of all potential risks is crucial for maintaining compliance and ensuring patient safety.
- Inadequate biological evaluation according to ISO 10993
Observation: ISO 10993-1 requires systematic data research and evaluation of materials in contact with patients or users (if product is intended for protection). Many manufacturers lack sufficient data to demonstrate the biological safety of their materials, leading to compliance issues. NSF's experience has shown that thorough evaluations and robust documentation are often missing.
Guidance: Conduct thorough literature reviews and evaluations of available data on materials. Prepare detailed biological evaluation plans and reports to systematically document the current state-of-the-art. We assist clients in minimising additional testing and ensuring compliance with ISO 10993-1, ultimately enhancing patient safety and regulatory standing. Proper biological evaluation is not just about meeting regulatory requirements but also about ensuring that materials used in medical devices do not pose any harm to patients or users.
- Post-market surveillance (PMS) documentation falling short of MDR/IVDR requirements
Observation: The MDR and IVDR have significantly heightened post-market surveillance requirements, yet many organisations struggle to meet these new expectations, resulting in nonconformities. NSF frequently helps clients develop and enhance their PMS documentation to meet these stringent requirements.
Guidance: Develop detailed PMS documentation in line with current guidelines. Implement robust systems to monitor and document post-market performance, ensuring continuous safety and effectiveness of your devices. NSF's expertise helps clients maintain product safety and regulatory compliance through regular updates and thorough documentation of PMS activities. Effective post-market surveillance is critical for identifying potential issues with devices after they have been placed on the market and for ensuring ongoing patient safety.
- Clinical evaluations not meeting MDR requirements
Observation: Clinical evaluations have become increasingly critical under new regulations, emphasising the importance of systematic data collection and analysis. Many manufacturers face challenges in conducting and documenting comprehensive clinical evaluations. NSF has supported numerous clients in navigating these complexities.
Guidance: Conduct systematic literature searches and clinical studies to gather robust clinical data. Document clinical evaluations thoroughly, including detailed plans and reports. Ensure compliance with MDR requirements for clinical data and device performance. Properly conducted and documented clinical evaluations provide the evidence needed to demonstrate that devices effective in accordance with the claimed intended use and safe from a clinical standpoint.
