a
adele_samson

Adele Samson

@adele_samson

FDA Medical Device and Regulatory Compliance Specialist

United States
English
About me
I am a regulatory affairs specialist with years of experience helping medical device startups and manufacturers navigate the FDA 510(k) submission process. I specialize in medical device classification, predicate device identification, substantial equivalence, and labeling compliance under 21 CFR 801. I have successfully prepared over 50 FDA submissions with a 100% acceptance rate. My approach is thorough and focused on efficient clearance. Contact me to get your medical device FDA cleared.... Read more

Skills

a
adele_samson
Adele Samson
Offline • 
Average response time: 1 hour

See my services

Medical Device Regulatory
I will prepare your fda medical device 510k submission report
From$150 / projectMore details
FDA & Food Safety Clearance
I will handle fda cfia mhra ema product compliance USA canada eu
From$80 / projectMore details