Our software is used by medical device organisations across the globe to manage the design control process. Configurations of our software have been approved as compliant with the FDA and MHRA requirements to plan, record, report and monitor all changes to design control documents, risk management and processes.
Design control SOP
Define and manage the requirements and processes for Design and Development of new products. Plan and manage the process for auditing of the Design History File.
Design & development planning
Document Manager enables you to manage a formal approval process. Furthermore, changes can be controlled using audit trails, notifications and electronic signatures.
Define the process for collecting user requirements, reviewing and approving those requirements and use Issue Manager for a formal process to resolve incomplete, missing, ambiguous or conflicting requirements.
Define the process for converting the requirements into physical manifestation using risk analyses, traceability matrices, detailed design specifications.
Design verification and validation
Plan, protocols, test data, verification and validation reports are all managed in a single system.
Design review SOP
Plan, schedule and record outputs of design review inspections and audits.
Detail the processes for planning and execution of the transfer of the design to manufacturing.
Read how each of our software modules helps you to comply with ISO 13485:2016, the FDA and MHRA requirements.
Read how Qualsys helps you throughout the system and process validation process.
We selected Qualsys's GRC solution as it can be operated on various platforms. We have a number of Linux users so the software had to operate under this environment as well as Windows. Qualsys have been very supportive during all phases of the project (Dave Beard in particular) and we look forward to becoming a long-term client.