The consequences of your software being out of compliance can be time- and budget-consuming: delays, failed inspections, FDA 483 warning letters and increased patient risk. SaMD and medical device software have unique compliance requirements that can be difficult to keep up with due to rapid changes. Unlike other companies that perform remediation, Orthogonal is specialized in software. We’ll help you resolve both the immediate issues and underlying problems, as well as establish efficient design controls specific to SaMD that will save you money and get processes to a higher quality faster.
Gap analysis is the review of internal operations against applicable regulations and other best business practices, like CFR 20.820, EU MDR and IVDR, ISO 13485, IEC 62304 and ISO 14971. We identify gaps in planning, requirements, risk management, design, verification and traceability, as well as in the tooling and techniques for efficient maintenance of design controls. From there, we provide you with a prioritized roadmap to get back into compliance.
Once gaps have been identified, the work of remediation begins. We guide you through the process of fixing the issues, closing gaps and adding in best practices to help you stay in compliance as you continue development. For clients on a tight deadline, we can lend the expertise and people to fix things for you, rapidly conforming processes to our industry’s standards and regulations.
Just as important as closing gaps is preparing you to handle the change inherent to developing SaMD. Preventative action is based on our best practices for staying in compliance, especially focused on Agile SaMD development. We’ll help you meld regulatory practices and Agile methodology together, supported by ALM/PLM tooling for rapid, iterative development that speeds time to market and reduces design control effort while improving compliance.
Orthogonal’s remediation service helps your product stay on time, on budget and within regulatory parameters without interruptions or slow-downs. Your developers can focus on their work, while your quality and regulatory teams and systems engineers maintain compliance and improve safety in a streamlined, efficient process.