Top 5 Technical Documentation Challenges for Medical Device Manufacturers and Their Solutions

August 5, 2024

Learn about the top technical documentation challenges identified through our extensive experience and how to overcome them. From addressing cybersecurity risks to streamlining clinical evaluations.

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 our 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

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. Our 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 our 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 organizations struggle to align their documentation with the latest ISO 14971 standard, published in 2019. Through our 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. Our 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. Our 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 minimizing 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 organizations struggle to meet these new expectations, resulting in nonconformities. We frequently help 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. Our 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, emphasizing the importance of systematic data collection and analysis. Many manufacturers face challenges in conducting and documenting comprehensive clinical evaluations. We have 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.

Best practices for effective technical documentation

Comprehensive planning and integration

Effective technical documentation begins with comprehensive planning. This involves identifying all regulatory requirements and standards relevant to the device and integrating documentation processes with design, development, and manufacturing workflows. Continuous collaboration among cross-functional teams ensures thorough and compliant documentation. Comprehensive planning helps ensure that all aspects of the product’s lifecycle are considered and documented, from initial design through to post-market surveillance.

Regular reviews and updates

Technical documentation should not be static. Regular reviews and updates are essential to maintaining compliance and addressing emerging risks. Establish a schedule for periodic reviews, update documents to reflect changes in regulations and product design and engage in continuous improvement practices. Keeping documentation up to date ensures that it remains relevant and accurate, which is critical for both regulatory compliance and internal quality assurance.

Training and competency building

Building internal expertise is crucial for maintaining high standards in technical documentation. Invest in training programs for staff on regulatory requirements and documentation best practices. Build cross-functional teams with expertise in key areas such as cybersecurity, risk management, and clinical evaluation, and encourage knowledge sharing within the organization. Training and competency building ensure that all team members are knowledgeable about regulatory requirements and best practices, which helps maintain high standards of quality and compliance.

The role of industry standards and regulations

Adhering to industry standards and regulations is fundamental to effective technical documentation. Key standards include IEC 81001-series for cybersecurity, ISO 14971 for risk management, ISO 10993-1 for biological evaluation, and regulations MDR and IVDR for post-market surveillance and clinical evaluation. These standards provide a framework for ensuring that all aspects of technical documentation meet regulatory expectations and industry best practices. By adhering to these standards, manufacturers can ensure that their documentation is comprehensive, accurate, and compliant with all relevant regulations.

Current issues and NSF’s expertise

We frequently assist clients with the preparation of submissions for the European and US market, as well as addressing specific questions issued by the authorities (e.g., FDA) during ongoing submissions. Our support for US submissions ranges from conducting regulatory assessments to identify potential pathways, engaging in direct communication with the FDA through pre-submission meetings, and preparing complete 510(k) premarket submissions. The FDA’s newly introduced eSTAR template has raised various questions in the industry. Alongside cybersecurity-related inquiries, many clients seek guidance on IEC 60601 conducted testing for medical electrical equipment. NSF provides comprehensive support in preparing responses and offers guidance based on extensive interactions and project experiences with the FDA, ensuring clients are well-prepared to meet regulatory expectations.

How NSF can help

At NSF, we bring a wealth of expertise and practical solutions to help medical device manufacturers navigate the complexities of technical documentation. Our services include:

Cybersecurity Documentation: We assist in identifying and documenting cybersecurity-relevant data, developing comprehensive strategies that align with the latest standards. Our experience with clients shows that tailored cybersecurity plans effectively mitigate risks and enhance data protection.

Risk Management: We help update and integrate risk management processes to comply with ISO 14971, ensuring thorough documentation and risk mitigation. Our approach has helped clients develop robust risk management frameworks that address all potential risks.

Biological Evaluation: Our experts conduct systematic evaluations and prepare detailed biological evaluation plans and reports in compliance with ISO 10993-1. By leveraging our expertise, clients can ensure that their materials are safe for patient use.

Post-Market Surveillance: We develop robust PMS systems and documentation to meet MDR and IVDR requirements, ensuring continuous regulatory compliance. Our practical solutions have helped clients maintain high standards of product safety and compliance.

Clinical Evaluation: We support systematic literature searches, clinical studies, and thorough documentation to ensure compliance with MDR requirements. Our comprehensive clinical evaluation support enhances the credibility and safety of our clients’ medical devices.

By partnering with NSF, manufacturers can leverage our extensive experience and industry knowledge to enhance their technical documentation processes, ensuring regulatory compliance and improving product safety and performance. Our hands-on approach ensures that clients receive practical, actionable solutions tailored to their specific needs.

Client focused solutions and results

With NSF’s support, clients have achieved timely market clearance and approvals despite tight schedules and unforeseen obstacles. We help organizations not only develop the best products but also navigate the regulatory landscape efficiently, ensuring their products reach the market. NSF also supports building internal competence in various topics such as cybersecurity, FDA-related matters, and the structure and preparation of technical documentation. Successful projects rely on effective communication and collaboration between NSF and our clients.

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Connect with our global team of experts and ex-regulators

For further guidance on technical documentation best practices and compliance, contact NSF. Our team of experts is ready to support your organization in meeting the highest standards of quality and regulatory compliance, paving the way for successful market entry and sustained product performance.