Services

Qserve America offers a broad range of services including:

• Strategic planning
  Many companies have a great concept for a new device or a line extension, but have no idea what regulatory pathway to follow or, even worse, select the wrong one, resulting in unnecessary expense and lost time. Qserve will work with you to identify the optimal regulatory pathway and submission strategy to get your product to market with the best clinical indications for use and in the least amount of time. With a broad knowledge of the FDA device classification system and an extensive network of contacts within the FDA, Qserve can determine when a product can be submitted following a standard procedure and when a meeting with the FDA is appropriate. Qserve will be at your side during any such meeting, acting as your interface with the FDA.
• 510(k), IDE, PMA
  Whatever classification your device falls into: Class I, Class II or Class III, Qserve can help you. We can prepare your regulatory documentation, submit it to the FDA, follow it through the process and help answer any questions the FDA may have. As your Official Correspondent, we will be the first point of contact with FDA, sparing you from any concerns about dealing with a US Federal Agency with which you may be unfamiliar. Read More>>
• QMS
  Knowledgeable about all the major quality systems (e.g. FDA QSR, ISO 13485, CMDCAS), Qserve can help you build a quality system that not only addresses regulatory requirements, but that will truly function as an effective and efficient management system. If your system is already in place, Qserve can assess it for compliance with the relevant requirements and provide assistance in modifying your system to comply as needed. For small organizations in start up or pre-start up mode, Qserve can provide part-time management of all quality and regulatory functions, saving you the expense of hiring personnel before they can be fully utilized.
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• Pre(clinical)
  With a thorough knowledge of FDA regulations and guidance documents, and working with the experts in the Qserve Group, Qserve America can identify the bench and animal testing requirements that may exist for your device. Because of our knowledge of the various regulatory requirements in places such as the EU and Canada, we can save you valuable time and money by ensuring that testing is done to satisfy these multiple regulatory requirements, another advantage of working with a company with international experience. Because Qserve has associations with major test houses around the world, we can recommend the appropriate off-site testing facilities, as needed, and we can manage the entire process.
• US Agent
  Foreign companies must have a US Agent that the FDA can contact as needed. More than just an address, Qserve America also will complete and review the forms you must file with the FDA, such as Establishment Registration and Device Listing, to ensure that your organization and products are properly registered with the FDA.
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• Training
  Qserve offers a wide range of training services. These include training in basic QMS, such as FDA Quality System Regulations (QSR), ISO 13485 and CMDCAS, as well as more advanced training in specific topics, such as Medical Device Reporting/Vigilance, Design Control, Validation and Project Management. Training is customized to audiences ranging from Senior Management to manufacturing line operators. Training can be done on site or at a central location. Courses can be conducted in as little as half a day or over multiple days as needed.
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• Audits
  In order to assess an organization for compliance to the appropriate regulations and standards it is necessary to audit the various processes and functions within that organization. Qserve provides Gap Analysis audits of all relevant processes, including design control, quality systems, management responsibility, process control, validation, maintenance and calibration, training, distribution, corrective actions/preventive actions (CAPA), complaint handling, and medical device reporting/vigilance. More than just auditing, based upon many years of industry experience Qserve will recommend practical solutions to any observations to enable your organization to come into full compliance in the most efficient way possible.
  In the event your company is inspected by the FDA, another regulatory agency or a Notified Body (NB), Qserve can attend the inspection and serve as a liaison between your company and the auditor(s). This can be especially useful when language may be an issue.
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• CE Marking
  As a member of the Qserve Group, Qserve America can help you achieve CE Marking for your device either independently or concurrent with your US regulatory strategy. This is another advantage of working with a company that has an international scope. With our knowledge of the EU MDD and our relationships with all the major Notified Bodies (NB), we can help select the NB best suited to your particular needs.
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• Validation
  Process and product validation come in many forms, for example equipment, environment (e.g. clean rooms), sterilization (heat, EtO, gamma) process lines and software. While each has the ultimate goal of proving with a statistically valid degree of confidence that the product or process reliably performs as intended, the methods for performing these validations vary widely. With years of experience in process and product validation and with the ability to utilize the experts of the Qserve Group as needed, Qserve America can work with you to develop your validation protocols. Because of our association with major test houses around the world we can recommend third parties that can perform the more complicated validations and Qserve can manage the entire process, freeing your personnel to work on other projects.
• Authorized Representative
  Foreign companies that wish to sell their products in the EU must utilize the services a European Authorized Representative (AR), who has a physical address in the EU and who is responsible for interacting with the Notified Bodies on matters such as Adverse Events (Incidents). Qserve works with Obelis, the preeminent AR in Europe and is pleased to recommend their services. Obelis will ensure that your organization is in full compliance with all of the regulations mandated for an AR. Again, because Qserve works with your AR, there is an efficiency obtained through the elimination of redundant and/or incorrect procedures.
• Distributor Search
  Because of our long association with various large manufacturers and independent distributors, if your organization does not desire or lacks the capacity to distribute your product, once it is able to be marketed, Qserve can help you find the best fit for a distributor or for a licensing agreement.