At GN Device Group, Inc we are experienced in leadership, accountable for overall project implementation, working with clients in the life sciences field, including pharmaceutical, biotechnology, IVDs medical devices / combination products.  We are a change agent who is passionate and results-oriented in all stages of bringing medical devices/combination products to market (from feasibility to post-launch activities).

Our company is based on the belief that our customers’ needs are of the utmost importance. Our entire team is committed to meeting those needs.

Our primary goals and focus:

• Provide consulting services to medical device and combination product organizations in support of technical design, quality, and regulatory activities required for successful development, commercialization and introduction of medical devices and combination products
• Development of QMS and Design Control system and standard operating procedures for medical device and combination product
• Remediation of DHF files for medical device and combination products
• Development of risk management and HFE activities
• Management of projects within established scope, schedule, and budget while adhering to all applicable regulatory requirements
• Ensuring risks have appropriate mitigation and contingency plans
• Support project management team members to ensure success of projects while maintaining customer service focus

We would welcome the opportunity to earn your trust and deliver you the best service in the industry.

Location:
217 Front Street Suite 4D
New York, NY 10038
greg.nitka@gndevice.com
www.gndevice.com
Tel 310.279.8110