Early in the project, we assess classification, intended use, claims, and target markets to determine the most efficient approval pathway. Whether preparing an FDA 510(k), De Novo, or PMA submission, or navigating EU MDR conformity assessment, SechMed ensures that design and testing activities efficiently fulfil regulatory expectations. This proactive planning helps avoid wasted effort, unnecessary testing, and costly redesigns while keeping timelines realistic and achievable.

We provide the design history file (DHF) and Technical Documentation required for regulatory clearance to market. They contain detailed records of design inputs, outputs, reviews, verification, and validation. Our processes ensure traceability from initial requirements through to final reports, giving regulators a complete, review-ready package.

Risk management drives, and is driven by, everything we do in SechMed.

Using ISO 14971 methodology, we systematically identify potential hazards and hazardous situations, evaluate risks, and apply mitigation strategies across all elements of the design, and across our product realisation processes.
At the end of each project, we supply our clients with not only a current Risk Management File, but also with the tools and knowledge to ensure it remains relevant and effective.

SechMed has extensive experience in dealing with novel devices and associated pre-submission meetings with regulators. This experience informs communication with the regulators and preparation of Technical Documentation in support of your submission to FDA, EU and other national regulators.

Human factors/usability are core to both patient safety and regulatory success. Following IEC 62366, we conduct task analyses, use-related risk assessments, and formative evaluations throughout development. We plan and execute summative usability studies, ensuring compliance with regulator expectations. By integrating usability engineering into our development process, SechMed provides clear evidence that your device can be operated safely and effectively in its intended use environment.

While regulatory approval is the gateway to commercialisation, it is not the end of the journey.  As part of our structured handover package, we will provide details of ongoing regulatory obligations, including routine testing, maintenance of sterlisation validation, real-time aging requirements, and post-market surveillance activities. This ensures your device not only launches successfully but continues to meet evolving regulatory, clinical, and user needs throughout its lifecycle.

We provide specialised support for medical device manufacturers with legacy devices requiring remedial work to bring their Technical Documentation up to State of the Art (SOTA). Our service covers devices seeking CE marking under EU MDR 2017/745 as well as FDA-cleared devices needing updates to meet the latest harmonized standards.

We assist clients whose devices have transitioned to MDR requirements or been reclassified under MDR, requiring updated documentation and systems.

Our team can prepare or upgrade your complete Technical Documentation and Quality Management System (QMS), including development or revision of essential processes and procedures for: Risk Management, Usability, Post-Market Surveillance (PMS), Customer Complaint Handling and Clinical Evaluation (CEP & CER)

Whether you need a full system overhaul or targeted remediation, we ensure your device documentation and QMS meet current regulatory and industry expectations.

SechMed is proud to work in close collaboration with IQC our trusted partner for all training and professional development needs.

IQC delivers high-quality, industry-focused training that complements SechMed’s offerings, helping our clients build capability and confidence across quality, regulatory, and operational disciplines in the medical device and life sciences sectors.