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Skills

  • ISO 13485
  • ISO 9001
  • Medical
  • Medical Device

Services

  • Medical Device Regulatory Expert

    $125/hr Starting at $35 Ongoing

    Dedicated Resource

    Provides medical device manufacturers expert guidance in meeting global medical device regulatory compliance such as, US FDA and CE Marking. Experience in developing ISO 13485, FDA QSR, cGMP, CMDCAS,...

    ISO 13485ISO 9001MedicalMedical Device

About

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:
BSI
UL
Intertek/ETL
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