We bring the expertise and experience to quickly assess your current state. Once this is done, we draft a plan to address any issues and update/provide any procedures with the appropriate documents and forms to enable compliance/conformity with world-wide regulations including 21CFR (FDA), EU MDR/IVDR and other geographies. The basis for our knowledge comes from involvement in drafting of ISO 13485:2016 and work with the Medical Device Single Audit Program (MDSAP), developed by IMDRF and the Medical Device Discover Appraisal Program (MDDAP) processes, developed by CMMI/MDIC with FDA under the Case for Quality program. This specifically includes the application of a risk-based approach
US Regulatory Submissions, Adverse Event Reporting (MDR/Vigilance) and US Agent
We provide the knowledge and know-how to navigate the submission process with the US FDA for both Pre-Market Approvals (PMA) and Substantial Equivalence (510k) pathways including the deNovo path. We have the people to assist your organization in adverse event reporting including setting up electronic Medical Device Reporting (eMDR) using the electronic gateway submission (ESG). In addition, we provide US Agent support for registered foreign companies. We can also assist in setting up reporting adverse incidents (Vigilance) in the EU and other geographies.
Product Technical Documentation
We will help your organization create, remediate and document the processes for maintaining your technical documentation (STED, Design and Development Files, Technical File/Design Dossier). This includes Post-market Surveillance (PSUR) and Clinical Evaluation Reports (CER).
Quality & Management Systems--Nonmedical Devices
Every company needs to establish systems to enable management of your business processes. We come alongside entrepreneurs to help establish the procedures with the appropriate documents and forms to ensure an easy implementation. The basis for this work is the involvement in drafting of ISO 9001:2015. Let's talk about risk-based thinking to improve your processes. In addition, we can provide training to your people on best practices to get the best value from your system.
Expert Testimony--Medical Device
Provide expert understanding of engineering analysis, product investigation, medical device industry regulations and legal testimony for litigation of adverse medical device experience.