michaelpic3

Michael Wetherington is the founder of MedicalRegs.com.  He has extensive experience in medical device regulatory and engineering.

[USA & Philippines]

james viney photo resized

James Viney is the Head of Business Development for MedicalRegs.com and LUX LCA.  He also has experience in Robotics Industrial Automation. [Malaysia]

dallas thomas resized3

Dallas Thomas is an RA consultant for MedicalRegs.com.  He brings to the team extensive and complementing experience on US FDA  regulations.

[USA]

AAEAAQAAAAAAAADyAAAAJDNlZDUwYzM3LTBlYTUtNGE3Yy05NDgyLWExNTkyMzg2NTI2ZQ

Dale Hallerberg is one of our Medical Device Expert and his experience include: [USA]

  • 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 includes: [Hong Kong]

  • 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 includes: [China]

  • CCC Mark
  • China FDA
  • IEC 60601 series standards certification
  • CB Scheme
garethpic

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 Diligence

[UK]

 

DT 2019 resized2

 

Darren Thomas is the CEO of Smart-Therapeutics, a UK-based company and an expert consultant for MedicalRegs.com

[UK]

 

 

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:

howard
pharmacatalent
ext (3)
ext (4)
dantestimonial
ext (2)
ext (1)
ext

#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