ABOUT

RACHEL NORTH is a Regulatory Affairs professional with more than a decade of healthcare government affairs and 

medical device industry experience. 

• Proven track record of developing and managing productive relationships with clients, partners, Congressional and Federal agency staffs. 
• Achievement in submission strategy and technical writing. 

NORTH MEDTECH helps clients navigate 

US FDA and global regulatory environments with expertise in medical devices, diagnostics and combination products. 

Regulatory Activities

• PMA, HDE, IDE, 510(k), Qsubs
• CE Technical Files
• Change management
• Labeling and promotion 
• Business procedures and audits

Therapy Areas

• Vascular intervention
• Cardiac rhythm management
• Neuromodulation
• Orthopedic surgery
• General surgery

Device Types

• Class I-III 
• Active and passive implants
• Software
• Diagnostics and therapeutics
• Mobile medical applications