RQMIS, Inc.

Overview

Welcome to RQMIS. The medical product life cycle rarely takes a linear path. RQMIS offers a unique combination of technical and clinical knowledge applied to the disciplines of regulatory strategy/submissions, clinical study design/management and quality systems design/compliance. This experience offers unparalleled support to the medical device, combination products, and biologics industry. Our goal is to provide our clients with a strategic combination of advice and support that will secure product approval, facilitate fast and cost effective market entry, and ensure continued compliance throughout the life cycle of your medical products.

Standards & Methodologies

RQMIS advises clients to focus on the design control and product realization process. RQMIS has found three principle areas of particular importance when focusing on the design and development process:

 Design input/specifications  Application of risk management  Design Transfer

Operational Environments RQMIS has experience working in both R&D and Manufacturing environments. Manufacturing technologies include the use of metals (machining/casting), plastics (extrusion), electronics, coatings and human tissue/cells.

In addition we have a unique knowledge in manufacturing implantable medical devices that are provided in both a sterile and non-sterile state to be sterilized by the end user.

Qualifications, Certifications, Accreditations & Licenses

*Product idea Classification, *Regulatory Clinical Strategy, *Premarket Submissions Technical Writing, *Clinical Investigations, *Quality Systems & Compliance, *Due Diligence, *Training