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