Get expert advice and implementation at every point in the product life cycle
We help established companies as well as start-ups with all their medical device Quality Assurance and Regulatory Affairs needs.
Our aim is to provide a personalised and exceptional service.
Our Services
What others are saying …
Angela Drew
I worked with Alexander to get regulatory clearance in US and EU for our products. Alexander was often thinking outside of the box, offering creative solutions, suggesting improvements and providing helpful information throughout the project and in a timely fashion. His extensive experience in regulatory and QMS allows him to prevent issues before they arise.
I would gladly work with Alexander in the future.
I would gladly work with Alexander in the future.
Camargo Pharmaceutical Services
Product Ideation Consultant
Ivy Cheng
Alexander has extensive knowledge of Quality Systems and Regulatory Requirements for Medical Devices. With Alexander on my team, I always had peace of mind knowing Alexander will deliver a well thought high-quality solution that will support my company’s needs.
Michael Mizrachi
Alexander is a knowledgeable and devoted QA and QC professional, always striving and succeeding to find the golden path that ensures compliance and continuous improvement while maintaining a pragmatical approach considering real-life constraints.
Alexander is also a people's person who has excellent communication and socializing skills and was very likable by everyone.
I'd love to work with Alexander in the future, and he has my warmest recommendations.
Alexander is also a people's person who has excellent communication and socializing skills and was very likable by everyone.
I'd love to work with Alexander in the future, and he has my warmest recommendations.
Philips Medical System Technologies
Q&R Director