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Kenneth S
@kenshawspecculo
EU Regulatory and Quality Affairs Specialist
Malta
Englisch
Über mich
I'm a biomedical engineer who has been working as a regulatory consultant for the past 10 years specialising in medical device and IVD regulatory and quality affairs in the EU and UK. I have previously led a team of consultants and worked to advance a leading EU Authorised Representative organisation.
I take pride in helping manufacturers get their medical devices to market and have worked with all types of devices including computer aided detection software, active implantable medical devices, pharmacogenomics, cardiovascular devices, and infusion pumps.
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Kenneth S
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Durchschnittliche Antwortzeit: 1 Stunde
Meine Dienstleistungen
Technische Texte
I will conduct a gap analysis on your technical files
Technische Texte
I will build eu mdr compliant technical documentation
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basaaij
Wiederkehrender Kunde
Niederlande
I had a very pleasant collaboration with Kenneth. I now have a clear, professional GAP assessment that will help us move forward with our project. The communication and feedback were excellent, and the project was delivered efficiently. I'm happy to work with Kenneth on future projects.
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