KMax MedTech Consulting

KMax MedTech Consulting (KMC) is a full-service consulting firm that helps cost-conscious small to medium sized medical device start-up companies commercially launch their products globally. We provide full service support in the following areas (so that our customers can focus on what they do the best). * Device product registration/listing (USA FDA 510(k) & PMA, EU MDD & MDR, China NMPA (previously cFDA), Japan MHLW) * Manufacturing establishment registration * Quality system & regulatory compliance (US 21CFR part 820 QSR, China GB standards testing & PTR, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, EU ROHS 2, REACH, WEEE) * Marketing strategy (Value proposition, Market research and target market refinement, SWOT / PEST analysis & competitive landscape, Digital marketing strategy * Business development (Expand sales channels into US, China and EU markets, Investor relations & Fundraising, Roadshows)