KMax MedTech Consulting

medical devices

About

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)

Technologies

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Keywords

marketing strategy business development fda regulatory mddmdr cfda medical device sales channel ce medical equipment manufacturing medical innovation global market entry r&d consulting regulatory affairs global healthcare market other scientific and technical consulting services market access regulatory affairs consulting market entry support regulatory compliance healthcare innovation acceleration healthcare innovation healthcare delivery services medical device development medical technology medical device regulatory strategy strategic marketing quality management systems clinical trial management

Location

385 Moffett Park Dr, Sunnyvale, California, United States, 94089

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