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In partnership with Lux Certify Asia Sdn. Bhd.

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Accredited Product Testing & Certification UK

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Medical Device Reliability Engineering

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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/or 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
  • Laser skin treatment
  • LED skin treatment
  • Conceptual design of laser/LED PPP treament device
  • Laboratory equipment
  • Catheters
  • Robotics and automation
  • Surgical overhead lighting systems and more

Formal Training:

  • Medical Device Directive (MDD)/MDR/USFDA
  • 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 "IEC 60601-1 Clear - The Intent of the Requirements"
  • 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

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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Dr. Gareth Jones is our Technical Advisor.

  • CEO/CTO/Founder of Tech Startups
  • Photonics/Sensor/LED/Lighting/Medical Products
  • EU/UN/UK & Malaysian Govt Consultant
  • Patent Expert Witness and VC Due Dilligence
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Darren Thomas is the CEO of Smart-Therapeutics, a UK-based company and an expert consultant for MedicalRegs.com

 

 

Darren has successfully submitted four products for FDA 510k submissions and taken through two products for full European medical device CE Marking. He has significant experience of dealing with the FDA, Korean FDA, Health Canada, Taiwan FDA, China FDA & Brazilian ANVISA

PROFESSIONAL QUALIFICATIONS

  • Member of the Chartered Institute of Marketing
  • Post Graduate Diploma in Marketing
  • Post Graduate Doctoral Research into the Safe Use of Lasers in Healthcare
  • Master of Philosophy
  • Master of Science degree in Medical Optoelectronic Systems
  • Bachelor of Engineering Honours degree

KEY TECHNICAL AREAS

  • Clinical Applications of light and plasma-based therapies
  • Health and Safety of the use of lasers plasma and pulsed light systems
  • R & D into novel light-based therapies
  • Clinical study protocol generation
  • Clinical application development and Marketing
  • Regulatory compliance and submissions – ISO13485 & MDD

Testimonials:

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#IEC60601 #ISO 13485 #ISO14971 #MDD #particular60601 #collateral60601 #FDA 510K #FDA PMA #MDD #CEMarking #Class I #ClassIIa #ClassIIb #riskassessment #riskanalysis #qualitymanagementsystem #compliance #medicaldevicedirective #machinerydirective #REACH #RoHS #lowvoltagedirective #93/42/EEC #QMS