QMS+ Consulting, LLC

At QMS+ Consulting, we focus on Quality! Our goal is to help you develop a robust Quality Management System (QMS) that integrates global regulatory requirements, and to help you manage your QMS. We do this by understanding your companies’ needs and working with your team to develop robust processes and coaching and mentoring team members. Our services are provided onsite or remotely. We are committed to providing exceptional consulting services that fit your needs. Our expert consulting can guide you through the ISO 13485:2016 Quality Management System certification process. We conduct gap assessments of your existing QMS processes and procedures and develop remediation plans. We help you execute to the plans as your needs dictate. We also provide auditing services to ISO 13485:2016 and MDSAP. Services are tailored to your needs, including writing of policies, procedures, and work instructions, training and mentoring on quality system processes, auditing, ISO 13485:2016 and MDSAP audit preparation, and support during regulatory audits and inspections.