Technical Documentation and Regulatory Compliance Services

Whether preparing for an FDA submission, a CE mark application, or post-market surveillance audits, our technical documentation and regulatory compliance services help you stay compliant with regulatory standards while minimizing the administrative burden on your team.

NSF provides comprehensive regulatory technical documentation and consulting services tailored for medical device manufacturers and pharmaceutical companies. We support compliance across the entire product lifecycle—from pre-clinical to post-market—enabling you to focus on growth and innovation.

Documentation creation and management

• Precise, compliant documentation across all lifecycle stages, ensuring regulatory standards are met from development to market.
• Seamlessly integrated with your broader operational and compliance systems to ensure that changes in device design, manufacturing processes, or regulatory requirements are promptly reflected minimizing the risk of non-compliance.

Regulatory consulting

• Expert guidance on navigating complex global regulatory frameworks, helping you mitigate risks and streamline compliance.
• Scalable and Flexible Services
• For smaller companies, our subject matter experts can assist in managing regulatory challenges without the need for in-house teams, while larger organizations benefit from scalable, specialist resources during peak periods or more complex projects.
• Aligned with your unique goals and regulatory challenges, whether performing initial gap analysis, adapting documentation to global standards, or optimizing processes to fit your workflows.
• By tailoring solutions to your requirements, we ensure compliance is maintained without disrupting operations, saving you time and resources while supporting long-term success.

Updates and remediation

Regulatory compliance across markets, including:

• Updates to risk management files (ISO 14971).
• Usability file updates (IEC 62366-1, 82304-1).
• Software documentation (IEC 62304).
• Cybersecurity documentation (IEC 81001-5-1).
• Evaluation of biological safety (ISO 10993-1).
• Creation of documentation to meet FDA 510(k), PMA, EU MDR, EU IVDR, and other global requirements.

Post-Market and Clinical documentation support

• Development of clinical evaluation reports (CERs).
• Creation of post-market surveillance (PMS) plans and reports.
• Preparation of periodic safety update reports (PSURs).
• Post-market support, including license renewals and regulatory updates, allows you to concentrate on core operations.

Proactive lifecycle management

• Ongoing management of documentation updates to reflect changes in device design, manufacturing processes, or regulatory requirements. This ensures compliance at every stage of the product lifecycle.

Premarket submissions and notifications

• Expert assistance for FDA 510(k), PMA submissions, and international regulatory approvals.
• Specialized technical writing services for clear, accurate documents that simplify approval processes and accelerate reviews.

Gap assessments and remediation

• Identification of documentation gaps.
• Correcting deviations and nonconformities in technical files with corrective actions to maintain compliance.

Technical file review and audit preparation

• Comprehensive review of technical documentation to identify and address deviations before audits or inspections.

Additional services

• Training Services: On-site or virtual training tailored to your team’s needs.
• Regulatory Authority Support: Assistance in preparing responses to feedback from Notified Bodies or regulatory authorities.

Global expertise
With 80 years in regulatory support, NSF brings unmatched industry knowledge to address your unique challenges.

Streamlined workflows
Efficient processes reduce time-to-market, ensuring faster compliance while maintaining your competitive edge.

Tailored solutions
Customizable packages and technology integrations ensure you get the support you need.

NSF is your trusted partner in regulatory compliance. From technical documentation to global regulatory consulting, our comprehensive solutions empower you to stay compliant, efficient, and focused on growth. With scalable services and unmatched expertise, we ensure your regulatory journey is seamless from start to finish.

We have compiled a list of articles and training courses on the issue of technical documentation to help you and your colleagues.

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

Why Rigorous Clinical Evaluations Matter: Strategies to Boost Safety and Compliance
Did you know that 40% of medical device submissions are delayed due to inadequate clinical evaluations? In the highly competitive medical device market, mastering clinical evaluations is not just a regulatory hurdle but a strategic imperative.