Services Overview

Preparation of Regulatory Submissions. Our experienced regulatory consultants can help your team with new device regulatory submissions, modified device submissions, and responding to regulator findings. We can enable the fast and efficient organization of filings both locally and globally. 

EU MDR Gap Analysis. As European markets switch from the Medical Device Directives (MDD) to the new Medical Device Regulations (MDR), medical device companies will be required to meet new and more rigorous guidelines. We can help you identify areas of greatest risk, as well as provide a detailed plan to ensure your devices remain in compliance. 

Development of Quality Management Systems. Get personalized help from our technical experts in the development and maintenance of your Quality Management System.  Depending on your identified market(s), we are able to provide QMS expertise for ISO 13485:2016, ISO 9001:2015, 21 CFR 820 and more. We firmly believe that a properly executed QMS will help your organization to thrive by having it work with you toward your end goal. A QMS that is non-functional, or not "right-sized", will hinder your goals and drain your resources. 

Virtual Audits.  Get the support you need with mock audits, internal audits, or extra assistance during or after a regulatory body audit. 

Remote Training. We recognize that sending a team to an offsite conference or bringing in an external trainer can be cost prohibitive. We can provide remote, real-time training to ensure compliance and provide live expertise for your team. 

Supplier Audits.  Suppliers must be qualified and monitored during your relationship. We can help conduct supplier audits - allowing your team to focus on other company priorities. 

Onsite Training.  Whether you  have discovered a training gap, or would like to ensure your team remains compliant with ever changing regulations, we can create an individualized training plan for your team.