Traditional laboratory investigations are widely accepted to be accurate, but are time consuming, expensive, and often require preparation of test samples. Likewise, devices such as, ventilators, dialysis, electrotherapy, cough assist, etc., were known to be complex, costly, space demanding and required trained personnel. In recent years manufacturers have adopted AI, IoT, big data, microelectronics, and biotechnology, to employ digital biomarkers, nanotech, mobile imaging, point of care testing and telehealth to promote fitness, support prevention, or enable treatment of innumerable ailments. The pace of innovation in medical devices has pushed the boundaries of risks warranting higher responsibilities, measurable standards, and better regulation.
SigmaCan can work with your own product development team to understand your devices, technology, business plan, risks and controls. Our team will then provide you with a regulatory pathway for your devices and assist in meeting the quality and testing requirements, standards, licensing, and maintenance needs at the federal and provincial (central or state) level.
The Sigma team can also provide you with advice, ranging from, size of the market and funding to competitive products and potential clients. If required the team can complement this with inhouse expertise in promoting devices across all provinces, payors, and purchasers. This could include listing of products, communication, product launch, promotion, distribution, sales, support and on going maintenance.
Check out the following links to see what SigmaCan has to offer: