After meeting with new medical industry clients, they have expressed that before coming to RQMIS they were unaware of the need to have a Quality Management System (QMS) in place at the beginning of their path to market. By having the QMS in place early, it allows the client to capture design change control and gather data and documentation that will be required to obtain FDA clearance of your product.
We have helped many of our clients by designing and implementing a QMS system in an average of 30-45 days.
Then over the next 4-6 months they used their QMS system to gather the data and documentation required by the FDA to submit their 510(k) or De Novo Submissions. This reduction in time could lead to a clearance for their 510(k) within the next 3-6 months or 5-7 months for their De Novo Submission.
This makes it possible for an 510(k) or De Novo clearance within a year or slightly longer, allowing them to get their products to market quicker.
RQMIS is experienced with designing and managing quality systems for companies ranging from start-ups to multi-location, internationally based companies with annual sales of over $400 million. The products manufactured at these facilities vary in complexity to include all classes of medical devices, permanent implantable devices, human tissue, electromedical devices, wearable devices, and active implantable medical devices. These facilities have achieved and maintained 21 CFR 820, ISO 9001, EN/ISO 14971, EN/ISO 13485, FDA HCT/P and Canadian CMDCAS compliance.
RQMIS conducted also on-site and remote audits of the various quality systems across the different departments in order to develop a gap analysis and ultimately help design a unified, company-wide quality management system. These steps are designed to help our client consolidate their overall QMS across all sites nationwide and provide validated design control data for future regulatory submissions in the US, Canada, EU, and UK.