MD squared's Venture QuickExamTM
Stage-defined assessment to evaluate the gaps towards implementation of medical devices
The Venture QuickExamTM is a complete assessment of all critical aspects to bring your clinical innovation to market. The aim of this QuickExamTM is to help you reaching essential MedTech milestones, to expand or accelerate your business. For start-up and scale-up companies, we define for each segment the level of maturity, show the gap to reach compliance with the requirements and identify the necessary steps to reach the next milestone(s).
- Product definition, Intended use and Classification;
- Addressable market and barriers, Standard of Care and treatment alternatives;
- Regulatory requirements and applicable standards (MDR/IVDR, FDA and SFDA);
- Clinical Evaluation, Clinical Data collection and Post-Market Clinical Follow-Up;
- Technical Documentation, Adequate Product Design and Validation;
- Risk based Quality Management System according ISO13485:2016.
