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Michael's Story...

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
  • Surgical saws
  • Surgical overhead lighting systems 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)

 

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Dale is one of our Medical Device Expert and his experience include:

  • Risk Management using ISO 14971, IEC 60601-1 and related standards
  • Engineering analysis using hazard-based safety concepts
  • Standards development for IEC Standards
  • Medical Electrical Equipment testing and investigations using IEC 60601-1 and its collateral and particular standards
  • Technical training development and delivery
  • CB Scheme and membership on the IECEE Medical Electrical Equipment Risk Management Task Force
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Jeffry is one of our Medical Device IEC 60601 expert and his experience include:

  • Evaluation and testing of medical devices per IEC 60601 series standards
  • Medical device and laboratory test equipment agency certifications
  • Medical device power supplies

Ms.  Yena is also one of our Medical Device Expert and her expertise include:

  • CCC Mark
  • China FDA
  • IEC 60601 series standards certification
  • CB Scheme
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In collaboration with Lebentech Innovative Solutions, Inc. for wider range of medical engineering services that's beyond regulatory.

 

Testimonials:

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