Search Team

Search by Last Name
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z
Back to Case Listing

Nemaris, Inc. is a leading developer of surgery planning software, including tools for measuring anatomical components for placement of surgical implants. When Nemaris needed FDA counsel to assist in obtaining marketing clearance for its first generation Surgimap Spine software, it relied on Fish & Richardson to draft the 510(k) premarket notification and guide it through the regulatory process.

""Fish has a good understanding of the FDA process and strives to seek the least burdensome path forward. Working with Fish helped to put us at ease, and their attorneys are a pleasure to work with." Virginie Lafage, CTO/CFO and Co-founder, Nemaris"

In-Depth

Nemaris, Inc. is a leading developer of surgery planning software, including tools for measuring anatomical components for placement of surgical implants. When Nemaris needed FDA counsel to assist in obtaining marketing clearance for its first generation Surgimap Spine software, it relied on Fish & Richardson to draft the 510(k) premarket notification and guide it through the regulatory process. Nemaris returned to Fish a few years later to obtain FDA clearance for its next generation Surgimap 2.0 software.

Nemaris found Fish’s approach to the 510(k) process to be very practical. As stated by Virginie Lafage, CTO/CFO and Co-founder of Nemaris, “Fish has a good understanding of the FDA process and strives to seek the least burdensome path forward. Working with Fish helped to put us at ease, and their attorneys are a pleasure to work with.”

Fish works with a wide variety of device manufacturers like Nemaris, ranging from software developers to laser manufacturers. We are closely following developments related to digital health, including the evolving FDA and FCC regulation of wireless devices and mobile medical apps.

Nemaris works with Keith Barritt, a Principal in our Medical Device and Digital Health teams.