Start-ups

At Suma Medtec our consultants each have years of development experience in the medical device arena. We can help you navigate the next steps to market and also prepare required documentation to complement the fluctuating capacities of your team. 

 

Areas of focus that we offer to start-ups are:

- Regulatory strategy based on device category and applicable regions

- Project planning and management

- Building a Quality Management System (QMS) that enhances overall efficiency of your work (besides, it’s required per ISO 13485, 21 CFR Part 820, and EU MDR/IVDR)

- Navigating the Design Control process from concept to launch

- Preparation and review of technical documentation

- Readiness for region-specific certification, with audit support

- Product submission to global regulatory authorities, with support during review