#FutureReadyHealthcare
Medical Devices
Make the most of your data to enhance your competitiveness and elevate customer experience
Existing medical device operations are
Challenged
to manage growing pricing pressure from disruptive new entrants
Unscalable
to meet increasing need for evidence and shift towards value-based care
Suboptimal
to leverage data and adapt to changing consumer requirements
What we do
We leverage deep expertise in design controls, product risk management and usability engineering to inform product development decisions. From business assessment to device and user assessment, we combine design thinking and human factors engineering to help you design innovative and competitive products. We also offer validation and verification services in software testing, 510(k) protocol development and testing, risk management and hazard analysis, so you embed regulatory compliance early in the design process itself and accelerate your product design-to-launch cycle.
We partner with you through the go-to-market strategy to commercial activation cycle to accelerate your product launch and ensure it is successful. Our MedTech experts finds gaps and opportunities in existing care pathways to identify product opportunities. We scan the competitive landscape and apply analytics to define market scope with health economics and outcomes research and market access studies.
We also map patient journeys and articulate the product value proposition. We define detailed user requirements through human factors engineering studies and user experience and product design. We also verify and validate the product and ensure it complies to specific regulations. We apply our digital-first commercialization expertise to launch the product and monitor its performance post-launch with deep insights from sales force effectiveness, forecasting and post-market clinical follow-up (PMCF) surveys.
With regulatory planning and operations, we support you with document management, publishing, document maintenance and copy review to accelerate approval processes. We build and compile technical dossiers for 510(k) submissions and technical documentation for EU MDR, EU IVDR, EU IVDD and SaMD compliance. We also help you with Quality Management System (QMS) implementation, certification and sustenance to ensure conformance to ISO13485:2016.
Our comprehensive range of document authoring and update services and technology-led literature search helps you manage operational and compliance needs better, while reducing risks and improving product performance. These include clinical writing (CEP/CER, SSCP, PEP/PER), post-market surveillance and update reports (PMS, PSUR), adverse event reporting and post-market clinical follow-up (PMCF) surveys.
