Software and Consulting Firms Partner to Help Medtech Companies With FDA Compliance

Grand Avenue Software has entered into a strategic relationship with SafeLink Consulting Inc. to help medical and dental device companies navigate the U.S. Food and Drug Administration (FDA) process, achieve compliance, and commercialize their products. 
 
“We are pleased to team with SafeLink to bring value to dental and medical device companies navigating the challenging regulatory and quality management environment,” Grand Avenue Software President/CEO Ron Schmitz said. “SafeLink’s expertise in helping medical and dental device companies achieve regulatory compliance combined with our 20-plus years of delivering best-in-class, affordable and scalable electronic quality management solutions (eQMS) is an ideal combination.”
 
As part of their strategic relationship, Grand Avenue Software and SafeLink will collaborate on projects for clients in the medical, dental, and life sciences space to streamline and automate their quality systems and workflows.  
 
“At SafeLink, we know how challenging the FDA process can be for medical and dental device companies, which is why we are committed to helping our customers enhance their compliance processes, improve document control and maintain a quality culture,” SafeLink Consulting President Mary A. Bartlett said. “We are confident that our deep risk management expertise, combined with Grand Avenue Software’s quality management software and support, will help companies achieve compliance quickly, standardize processes, increase productivity, control overhead expense and ultimately increase profit.”
 
Grand Avenue provides a quality management software solution for medical product companies. The Grand Avenue Software team has extensive experience in software development, Software as a Service (SaaS) delivery, and quality compliance, specifically for the life sciences industries. Grand Avenue’s team works with startups, emerging growth, and established companies to navigate the complex regulatory affairs and quality assurance environment. 
 
Since 1991, SafeLink Consulting has been educating the dental industry by preparing them with the day-to-day health and safety requirements needed to meet OSHA standards and CDC guidance. SafeLink also assists laboratories and medical devices manufacturers with quality systems and establishing Good Manufacturing Practices (GMPs) required by the FDA. SafeLink Consulting is nationally and internationally recognized for providing virtual and onsite training, assessments, and seminars to diverse audiences.