Michael Wetherington 1

Jacksonville Beach, Florida, United States

Yearly Stats: $0 Earned |

The guru of


Michael Wetherington 1

Accurate and complete regulatory services for global markets from ISO 13485/QSR to regulatory submissions

Michael B. Wetherington founded both Adept Engineering Solutions, Inc. (AES) and Martela (US-based companies). 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 (Keratectomy)
Blood infusion pump (includes rapid infusion for battlefield casualties)
Female urinary incontinence device
Hospital beds (bariatric, proning and standard beds)
Lithroscopy/Lithrotripsy device
Wound therapy devices
X-rays and Gamma imaging
Dental chairs and equipment
LED and laser skin therapy devices
Surgical saws and more

Formal Training:
Medical Device Directive (MDD)
Medical Device Software
Transport and Storage
Clinical Documents
IEC 60601-1 2nd and 3rd editions
IEC 60601-1-2 EMC (Designing for EMC)
IEC 60601-1-4 PEMS - IEC 62304
IEC 60601-1-6, IEC 62366 Usability Engineering - Human Factors (HFE)
IEC 60601-1-8 Medical Alarms
IEC 60601-1-9 Environmentally Conscious Design
IEC 60601-1-11 Home Healthcare
FDA Design Controls - Requirements and Industry Practices
ISO 13485 Internal Auditor
ISO 14971

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:
TUV America (contract)
Wyle Labs (contract)

Work Terms

I'm flexible working in multiple time zones to accommodate my customers. Responsive and strong work ethics.

#ISO13485 #MDD #510K #QSR #MDR #ISO14971 #IEC60601 #CEMark #CBScheme #QMS #ISO9001 #NotifieBody