Medical Devices - Jacksonville Beach, Florida, United States
Michael's Story...Michael B. Wetherington founded both Adept Engineering Solutions, Inc. (AES) and Martela. Then later, created MedicalRegs.com as a spin-off to provide more focused services in the medical device arena.He has both electronics/electrical engineering and business background whose combined experience in both areas span over 20 years.His specific experience in the medical device industry include; product agency certification, regulatory and medical device research & development.Device Regulatory and R&D Experience:Vision correction laser systemBlood infusion pumpFemale urinary incontinence deviceHospital bedsLithroscopy/Lithrotripsy deviceWound therapy devicesX-rays and Gamma imagingDental chairs and equipmentSurgical sawsSurgical overhead lighting systems and moreFormal Training:Medical Device Directive (MDD)Medical SoftwareIEC 60601-1 2nd and 3rd editionsIEC 60601-1-2 EMCIEC 60601-1-4 PEMS - IEC 62304IEC 60601-1-6 Usability Engineering - Human Factors (HFE)IEC 60601-1-8 AlarmsIEC 60601-1-9 Environmentally Conscious DesignIEC 60601-1-11 Home healthcareFDA Design Controls - Requirements and Industry PracticesAccomplishments & Memberships:Who's Who of International Entrepreneurs 2000Former member of American EntrepreneursPartnered with a $1 billion certification agency through AESEnvironmentally conscious design team leaderAuthor of "Resume4today - Think Like a Marketing Pro"Author of "IEC 60601-1 Clear - The Intent of the Requirements"A level 1 digital marketer on FiverrDeveloped engineering training handbooks for UL on anesthetic workstations, x-rays, infusion pumps and medical alarmsNRTL and Notified Body Experience:BSIULIntertek/ETLTUV America (contract)Wyle Labs (contract)
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