About Us

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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 we can help you manage your QMS. We do this by understanding your companies needs and working with your team to develop robust processes and we provide coaching and mentoring to your team members. Our services are provided onsite or remotely.

We are committed to providing exceptional consulting services that fit your needs. Our expert consultants can guide you through the Quality Management System certification processes under ISO 13485:2016, ISO 9001:2015, or MDSAP.

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 FDA 21 CFR Part 820, ISO 13485, ISO 9001, and MDSAP.

Services are tailored to your needs, including writing of policies, procedures, and work instructions, training and mentoring on quality system processes, auditing, FDA, ISO 13485, ISO 9001 and MDSAP audit preparation, and support during regulatory audits and inspections. QMS+ experts in medical devices can assist your team in all aspects of compliance, regulation and standards.

We offer our services fluently in English or Spanish.