The traditional 510(k) FDA is a primary vehicle for clearing a medical device for sale in the US. The key to getting clearance in the least amount of time is understanding and anticipating FDA concerns.
RQMIS provided Regulatory and Quality support to a startup company to gain the FDA clearance
RQMIS assumes management of the study, assesses its current status, and corrects its deficiencies.
RQMIS gets combination product clearance.
In less than 6 months, RQMIS was able to get this study data cleaned, queried, and locked, officially closed-out the study, and the published data both in the Sponsors TF as well as in a journal.
RQMIS develops and implements a post-market clinical study in support of a new marketing claim.
RQMIS develops and implements a Phase IV clinical study.
An in vitro medical device is looking for a pathway to collect clinician feedback on its potential usages and applications for FDA submission.
A China manufacturer now has a fully operational company in the EU, which is EN/ ISO13485: 2012 Certified. The manufacturer minimized use of internal resources by using RQMIS
The client passed its notified Body (NB) audit in February of 2013. NB provided very positive feedback on the improvements.
RQMIS helped the North American division of a Japanese medical device manufacturer in addressing observations identified in a FDA Warning Letter regarding Complaint Handling which lead to the processing, investigation, and closing of 10,000+ backlogged complaints.
RQMIS enabled the manufacturer to complete a successful audit of a combination product manufacturing facility, with a finding of only four minor observations, and a VAI (voluntary action indicated) rating.
RQMIS helps an international client introduce a medical device to the US market
RQMIS helped a manufacturer address the issues targeted in the FDA warning letter in less than two weeks.
RQMIS' recommended process changes improved efficiencies throughout a company.
RQMIS helps re-establish a Class III implant manufacturing process.
RQMIS was able to save this client substantial time, effort and money by eliminating the regulatory requirement to bring the client’s product to market.
RQMIS helps US manufacturer design and conduct retrospective clinical study on device used to treat pancreatic cancer.
RQMIS works with the FDA on a client's behalf to determine a pathway to market
RQMIS supports the client's recent acquisition by helping to resurrect the ongoing clinical study.