Medical Equipment - N/A, N/A, N/A
If you have…Developed a new medical device, and now you want to get it cleared by FDAJust been called by FDA or your notified body and they will be inspecting or auditing your facilityJust received an FDA-483 that you need to respond to in 15 daysA quality system that is managing youCompliance with ISO 13485, but you need to upgrade to ISO 13485: 2016A need for a LEAN, Audit Tested Quality Management System for your small to mid-size companyBecome aware of the need to conduct or close out a Medical Device RecallWe can help! With over 20 years of experience in the medical device quality assurance and regulation industry, as FDA Consultants Medical Devices we can assist you with…Writing 510(k)s for complex electro-mechanical devices and Software as a Medical DevicePreparing facilities and training employees to optimize FDA and ISO inspection and Quality Audit outcomesResponding to FDA and ISO inspection observations by creating remedial action plans and preparing responses that anticipate potential objections by the agenciesWriting, implementing, managing and defending ISO, FDA, CMDCAS quality systemsImplementing fully compliant Quality Management Systems in three weeks or less
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