TECHNICAL DOCUMENT AND COMPLIANCE SUPPORTAll the Documents You Need for Medical Device Approval

Implement an ISO 13485:2016-compliant Quality Management System (QMS) to ensure regulatory readiness and drive continuous improvement. We develop QMS for new and existing devices, review current systems, and perform gap analyses to maintain high-quality standards.

We provide end-to-end preparation of medical device technical documentation to support regulatory approval. Our approach covers MDR Annex II & III requirements, clearly defines intended use and target users, and compiles comprehensive device, design, and manufacturing information. We verify compliance with GSPR, conduct thorough gap analyses, and prepare labeling, instructions for use, and other device information in line with current MDCG guidance.

We provide comprehensive support for Clinical Evaluation Plans (CEP) and Reports (CER) to meet EU MDR requirements. CEPs and CERs are developed in compliance with MedDev and MDCG guidance, integrating clinical data from literature, studies, and post-market sources. Device safety, performance, and benefit-risk profiles are evaluated, ensuring alignment with technical documentation and regulatory requirements, and supporting Notified Body review and audits.

We conduct comprehensive literature searches and reviews to support clinical evaluation and regulatory compliance. This includes performing SOTA (State of the Art) reviews, structured inclusion/exclusion screening, and critical appraisal of evidence for integration into technical documentation and Clinical Evaluation Reports (CER), all in line with MedDev and MDCG guidance.

We implement structured risk management to ensure device safety and regulatory compliance. Risk management files are prepared in accordance with ISO 14971:2019 and maintained for regulatory submission and Notified Body audits.

Ensure reliable device approvals with tailored PMS and PMCF systems aligned with Clinical Evaluation and Risk Management. We prepare PMS Plans, PSURs, and PMCF Reports, collate and analyze post-market and clinical data, and ensure compliance with MDR and relevant guidance.