Sconce Solutions enables end-to-end capabilities and processes for the unification of the engineering, quality and regulatory data for medical device innovators.
For over more than a decade, we are a trusted consulting and implementation partner for some of the global leaders in medical technologies. We deliver value by the following solutions and services:
- Implement the best practices for defining and maintaining DHF and DMR for effective and efficient design and document control
- Streamline the change notice process for UDI submissions for Class-I, II, III devices to FDA
- Implement a close loop change and quality processes by unifying the engineering, quality and regulatory world
- Implement quality to ensure that all customer complaints, audit findings, product and processes non-conformance (NC) are digitally captured and are traceable for closure.
- Implement CAPA processes to ensure corrective actions for existing issues and preventive actions to avoid recurrence
- Enable training tracking framework to ensure that existing and new users/ employees for the latest releases of forms, procedures and specifications
- Perform or liaise with external consulting firms for the process validations – Installation, Operations and Performance Qualifications.
- Implement core PLM capabilities like parts, bill of materials (BOM) and manufacturing resources and processes (BOP) to build the digital thread for E2E traceability
- Perform data migrations since many of our medical devices companies have been very actively involved in merger and acquisitions in the last one decade.
- Build integrations between enterprise applications, especially PLM and ERP for smooth and real time data flow across the enterprise.
Key Success Stories