Founded in 2003, Med Dev Global Solutions is a strategic advisory firm that creates quality, regulatory, clinical, technical, and business solutions from concept to post-market for medical device companies worldwide. With support in each major region of the world, we help obtain regulatory approvals and bridge the gap to markets in countries that make up more than 80% of the global medical device market. We have extensive experience in the medical device industry. We understand global regulations and how to apply them to your products with cost-saving precision. This gives us – and you – a major strategic advantage. With our deep-domain expertise, we are strongly equipped to provide you with better information sooner in your products’ evolution. Successfully obtaining timely market approvals with less surprises along the way is a wonderful position for your business to be in. We help businesses, scientists, engineers, and physicians define exceptionally clear paths to achieve their objectives. Deep Medical Device Expertise: • Global Regulatory Compliance, Submissions, and Approvals (FDA 510(k) & PMA, CE Marking, SFDA, PMDA, Shonin, Ninsho, etc.) • Quality Management Systems (QMS), Audit Support, and Training • Medical Device Design and Development • Product Development Process • Scientific & Technical Analysis • Business Strategy • Product Commercialization • Global Distribution