JAH Associates LLC
Expertise in toxicology and drug and medical device development

Medical Device Development



Medical device development services include:


Review and gap analysis of nonclinical and clinical data


GLP audits of Contract Research Organization sites


Study design and monitoring and report writing for Biocompatibility evaluation (ISO 10993 and G95-1) 


Preparation of documentation for regulatory submissions (510k, IDE, PMA)


Preparation for FDA and business-related meetings


Regulatory authority correspondence


Project Management