Patent Filing and IP management
STD Med employs subject matter experts within the various fields of medical device technology. We can provide investigations and due diligence in support of Patent Applications and other efforts to secure Intellectual Property.
Quality System Implementation
STD Med has an established and well defined Quality Management System. This system and the team that maintains and improves it can provide start-up companies with their own customized Quality Management System capable of meeting ISO and FDA standards.
STD Med has the resources needed to meet the regulatory and legal needs that arise during Product Development and throughout Production. We have extensive experience operating within the regulatory requirements of the FDA for various submission types (e.g. 510(k), PMA) as well as outside of the US for CE Marking and various foreign government agencies including Canada, South America, and Asia. Our legal team is well versed in the processes required for the protection of Intellectual Property. STD maintains a deep understanding of the systems and regulations needed to bring a product to market, which allows for an effective and efficient strategy to be developed that serves the business needs of our clients
STD Med has audit-tested design control procedures compliant with FDA 21 CFR820.30. Our Engineering and Quality personnel are well-versed in the proper execution of Design Control, which has provided the ability to successfully bring many products to market over the years. STD Med is able to serve as the Design Control authority for your burgeoning company, should a quality system not yet exist, or to operate entirely within your well-established system for those companies with more experience in Design Control.
Clinical trials are designed to determine the safety and effectiveness of investigational devices in human patients. At STD Med we have extensive experience with global trials and our support services provide complementary resources and expertise to enhance your studies.
During each trial phase a multitude of scientific and professional services are required to satisfy the regulatory requirements of device licensing authorities. STD Med offers a wide range of clinical support services, specialty programs, process manufacturing testing, and regulatory advisory personnel to help bring your new device into the marketplace.
STD Med is experienced in the inspection and processing of surgical instruments typically returned from the field following hospital usage. We can tailor a process for cleaning and preparation of these instruments to quickly return instrument sets to a "ready" position.
Regulatory standards require the evaluation of suppliers, contractors, and consultants. We can address these customer requirements by performing the evaluation through on site audits to confirm the suppliers, contractors, and consultant's ability to perform defined processes, confirm product traceability and establish procedures and the documentation needed to support these regulations and any additional customer needs.
Finished Product Distribution, Hospital order fulfillment
STD Med provides complete device manufacturing and distribution services. We have secured areas and systems which link us to our customers and their order fulfillment system. We can "pick and pack" product for drop shipment around the globe.