With over 10 years of experience, Alex supports global medical device manufacturers with navigating the complexities of the international medical regulatory landscape, specializing in compliance, particularly in product safety and IEC 60950-1.

Alex’s expertise has expanded across several other safety standards, including IEC 62368-1 and IEC 61010, which served as a stepping stone to his current medical expertise. From 2020, Alex has been one of Element’s leading UK medical experts, looking at the Risk Management, usability and software side of the compliance sector.


Experience/Industry experience

Alex’s main role is Senior Medical Engineer and is responsible for leading Element’s UK medical device testing projects. Alex takes ownership of projects on behalf of the Engineers and Technicians within the safety group, and to support customers understand their testing and compliance requirements, with knowledge of both general product safety and medical equipment safety. Alex specialises in Class I, II, and III devices, supporting manufacturers across home healthcare equipment and wearables, and hospital-based medical equipment.

 

Specialisms

  • Global regulatory expertise across, MDR, FDA, IEC 60601 
  • Home healthcare devices  
  • Medical device testing and compliance

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Content by this Expert

Testing medical devices to home healthcare standards Understand the compliance requirements White Paper

Testing medical devices to home healthcare standards Understand the compliance requirements
03/24/25

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