OUR STRATEGY
We are able to understand and interpret the current regulations and have in-depth awareness of how to apply the standards to business facilities and operations. QRT consulting services not only delivers an effective strategy for handling compliance issues, but our team has the skill to go beyond analytical assessments and collaborate with clients to develop clear implementation strategies.
Our hands-on, customer focused approach is based on our experience with regulations. Our focus is on Medical Devices and we provide comprehensive compliance solutions that are customized to your operations and business strategies.
As Small to Medium sized Medical Device businesses face ongoing compliance challenges, increasing market demands and the drive to reduce costs, QRT can support you by implementing full-service solutions that ensure compliance is attained.
With experience across the industry, we deliver strategies in a broad spectrum of areas that include but are not limited to the following services:
– CAPA handling and closure
– Preparation of responses to FDA 483, citations, and warning letters
– Compliance audits, assessments, and gap analyses
– Validation
– Regulatory strategy development
– Complaint handling and recalls (FDA 21 CFR Part 803) Supply-chain
– Medical device gap assessment & audit preparation for ISO 13485:2016 & MDR (93/42/EEC & 90/385/EEC)
– ISO 13485, 10993, 14971
– UDI Implementation
Our ability to customize an assess where compliance improvements are needed, utilize best practices for resolving them and remaining flexible and agile during the execution of the plan of action is what distinguishes our organization from other consulting firms that focus on larger businesses.
