JHG Consulting helps medical device companies navigate complex regulatory requirements.

Julie Grill, Principal Consultant, has over 25 years of experience as a Regulatory and Clinical studies professional, achieving numerous regulatory objectives in the medical device industry, including:

• Obtaining PMA, HDE, IDE, 510(k), CE Mark, product modification approvals, and other international regulatory approvals for novel medical devices, including active implantable neurostimulation and other neurodevices, surgical tools, etc.

• Participating on product development teams for medical device companies

• Planning and conducting clinical trials (feasibility through pivotal) for medical devices for early stage companies

• Experimental design, data collection, data interpretation, and report generation for clinical studies

• Delivering persuasive technical writing for regulatory submissions, reports, publications, grant applications, and business plans

• Building systems for regulatory compliance'

• Addressing the full spectrum of issues facing early medical device companies

• Operation in a small business environment where agility and creativity are necessary for success

As an integral part of your team, JHG Consulting will perform with excellence!