MedicalRegs.com Information

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 system Blood infusion pump Female urinary incontinence device Hospital beds Lithroscopy/Lithrotripsy device Wound therapy devices X-rays and Gamma imaging Dental chairs and equipment Surgical saws Surgical overhead lighting systems and more Formal Training: Medical Device Directive (MDD) Medical Software IEC 60601-1 2nd and 3rd editions IEC 60601-1-2 EMC IEC 60601-1-4 PEMS - IEC 62304 IEC 60601-1-6 Usability Engineering - Human Factors (HFE) IEC 60601-1-8 Alarms IEC 60601-1-9 Environmentally Conscious Design IEC 60601-1-11 Home healthcare FDA Design Controls - Requirements and Industry Practices Accomplishments & Memberships: Who's Who of International Entrepreneurs 2000 Former member of American Entrepreneurs Partnered with a $1 billion certification agency through AES Environmentally conscious design team leader Author of "Resume4today - Think Like a Marketing Pro" Author of "IEC 60601-1 Clear - The Intent of the Requirements" A level 1 digital marketer on Fiverr Developed engineering training handbooks for UL on anesthetic workstations, x-rays, infusion pumps and medical alarms NRTL and Notified Body Experience: BSI UL Intertek/ETL TUV America (contract) Wyle Labs (contract)