Description: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.
RQMIS, Inc. 29 Water Street, Suite 305 ,
Newburyport, MA, United States 01950
Products and Services: RQMIS can provide both comprehensive service that addresses all aspects of achieving regulatory marketing clearance and insurance reimbursement of their products or they can provide focused advice on specific issues or concerns. Comprehensive service can provide your company a road map of all of the issues you need to address to achieve/maintain marketing clearance and insurance reimbursement. RQMIS, as a partner with your company, will then execute this plan to assure effective implementation. In a more focused role, RQMIS can provide support in writing individual marketing submissions, manage a clinical study, advise/draft responses to regulatory bodies, perform health hazard evaluations, etc. RQMIS is very adaptable to the current needs of its clients.
Experience: **Important Note: This information has been provided by the Company and has not been confirmed by Contract Laboratory Inc. It is recommended that you confirm all information prior to using this Company .*Product idea Classification, *Regulatory Clinical Strategy, *Premarket Submissions Technical Writing, *Clinical Investigations, *Quality Systems & Compliance, *Due Diligence, *Training
Featured Products and Services
*Draft ISO 9001:2015, * New European Office, *Human DNA can't be patented, Supreme Court Rules.
RQMIS believes the best client is the one who understands the challenges and complexity of the numerous standards and regulations governing medical device development, manufacturing and sales/marketing. We try to make every consulting experience with a client an opportunity for them to better understand the issues that surround them and how to interpret and apply the relevant standards/regulations to their situation.