Narvitas Medical Devices International Limited Announces Strategic Alliance for Regulatory & Quality Assurance

Monroe Medical Device Consulting to file FDA 510k for Narvitas' Proprietary LapDome device
 
Lapdome
Lapdome
LONDON - July 29, 2016 - PRLog -- Narvitas Medical Devices International Ltd (Narvitas) today announced the signing of a strategic alliance with Monroe Medical Device Consulting LLC, a leading US-based consulting firm specializing in medical device regulatory submissions. The initial purpose of the alliance is to file an FDA 510k for the proprietary LapDome device manufactured and marketed by Narvitas. LapDome is the first device of its kind in the market whose function is to reduce the complication rates and procedure times for laparoscopic surgery access.

"With the current launch of the CE-Mark certified LapDome device in Europe now underway, it is an appropriate time to team up with a respected regulatory and quality assurance consulting firm. Monroe Medical Device Consulting is the perfect fit for Narvitas in the US," noted Glenn Foley, Chief Executive Officer for Narvitas. "This is a continuation of our strategy to align with the best partners in the industry."

About LapDome® Laparoscopic Access Device

LapDome addresses a critical need in the laparoscopic surgical market (one of the largest medical procedure markets) and was developed to advance the standard of care for laparoscopic access. The LapDome device is a proprietary laparoscopic surgical access device. The device is a dome-shaped technology that utilizes negative pressure to raise the anterior abdominal wall for rapid and safe access of the abdomen by surgical instruments.

About Monroe Medical Device Consulting LLC

MMDC was founded in June of 2013 under the premises of organizing a strong management group that would: 1) work to leverage existing technological skills to establish a foothold in the global medical device market through partnerships and collaborations, and 2) grow the company by expanding and diversifying our medical device technological capabilities through certifications, professional societies and industry intelligence. With a combined time span of 20 years working on the design and development of hardware and software devices ranging from lasers, radio frequency coils, and micro-controllers coupled with post-processing imaging analysis, MMDC has poised itself on the forefront of the cutting edge of highly complex medical devices to improve the quality of patients' lives.


www.narvitas.com

Contact
Glenn Foley
Chief Executive Officer
gf@narvitas.com

Photo:
https://www.prlog.org/12576239/1
End



Like PRLog?
9K2K1K
Click to Share