Menu
Address
920 Aspen Court, Boston
Clinic Hours:
9:00am – 5:00pm (Mon-Fri)
Clinic Number
(857)-200-1031
Emergencies:
(617)-350-2714
Menu
920 Aspen Court, Boston
9:00am – 5:00pm (Mon-Fri)
(857)-200-1031
(617)-350-2714
Requalite CRO segment is a full clinical study service department providing the device manufacturers to conduct clinical studies in Europe as per IVDR, MDR, and other applicable global regulations. We identify the best clinical settings to perform your device testing and perform your clinical study. Whether you require a diagnostic study (clinical performance study) or medical device study (clinical investigation study) as per EU compliance, we are here to help you to obtain timely, effective, and scientifically sound study to help your device in performance and safety.
The MDR defines clinical investigations as follows: “Systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a medical device.”
Clinical investigations are performed to assess the safety and performance of a medical device. Requirements are outlined in the MDR specifying submission, assessment and the conduct of clinical investigations.
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We offer support to manufacturers and sponsors to perform CPS compliant with the current regulations. This includes assistance in designing the CPSP, preparation of documents for the registration at the ethics committee and the German Federal Institute, competent partnership for the study sites including monitoring visits as part of our CRO services, assistance with the preparation of the CPS report.
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Clinical performance studies (CPS) are performed to confirm the analytical and clinical performance of a device. CPSs are performed when device safety and performance cannot be determined by literature or pervious experiences obtained through diagnostic routine testing. The studies are based on the clinical performance study plan (CPSP), and collected data is used for performance evaluation processes. Specific requirements for CPSs are outlined in the IVDR.
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Post-Market Surveillance (PMS) is a continuous, active and systemic process of gathering, recording and analysis of relevant data on the quality, performance and safety of a medical device (MD) (including in vitro diagnostics devices – IVDs) throughout its entire lifetime. The PMS in conducted within the framework of a PMS plan (PMSP). Results and conclusions of a PMS are summarized in a Post-Market Surveillance Report (PMSR). Additionally, the PMSR describes any preventive and corrective action taken as a result of incidents related to the medical device. PMSP and PMSR are part of the technical documentation of PMS for devices.
According to the European Union (EU) Medical Devices Regulation (MDR) (MDR 2017/745), manufacturers of class I MDs are required to prepare a PMSR, to update when necessary, and to make available to the competent authority upon request. Similarly, manufacturers of class A and B IVDs are required to prepare, update, and make available the PMSR for their IVD according to the In Vitro Diagnostic Regulation (IVDR 2017/746).
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Our service also includes preparation of documents for the registration at the ethics committee and the German Federal Institute, competent partnership for the study sites including monitoring visits as part of our CRO services.
At times, manufacturers are required to conduct a clinical study during the development of the device for testing the performance, safety, and applicability of their devices. These studies are generally not used to support the regulatory compliance process rather to help manufacturer in device development phase. Requalite with its vast network of clinics and hospitals in all over Germany is capable of providing you to conduct such R&D studies. We also support you to develop and design your studies to obtain best possible outcome which also helps you to maintain your budget limits.
Sunt in culpa qui officia mollit natoque
We offer support to manufacturers and sponsors to perform CPS compliant with the current regulations. This includes assistance in designing the CPSP, preparation of documents for the registration at the ethics committee and the German Federal Institute, competent partnership for the study sites including monitoring visits as part of our CRO services, assistance with the preparation of the CPS report.
Mollit natoque consequat massa quis
Ut enim ad minim veniam quis nostrud
Post-Market Surveillance (PMS) is a continuous, active and systemic process of gathering, recording and analysis of relevant data on the quality, performance and safety of a medical device (MD) (including in vitro diagnostics devices – IVDs) throughout its entire lifetime. The PMS in conducted within the framework of a PMS plan (PMSP). Results and conclusions of a PMS are summarized in a Post-Market Surveillance Report (PMSR). Additionally, the PMSR describes any preventive and corrective action taken as a result of incidents related to the medical device. PMSP and PMSR are part of the technical documentation of PMS for devices.
According to the European Union (EU) Medical Devices Regulation (MDR) (MDR 2017/745), manufacturers of class I MDs are required to prepare a PMSR, to update when necessary, and to make available to the competent authority upon request. Similarly, manufacturers of class A and B IVDs are required to prepare, update, and make available the PMSR for their IVD according to the In Vitro Diagnostic Regulation (IVDR 2017/746).
Lorem ipsum dolor sit amet consectet
Our service also includes preparation of documents for the registration at the ethics committee and the German Federal Institute, competent partnership for the study sites including monitoring visits as part of our CRO services.
Lorem ipsum dolor sit amet consectet
Lorem ipsum dolor sit amet, consectet adipiscing elit,sed do eiusm por incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis
Ut enim ad minim veniam quis nostrud
Lorem ipsum dolor sit amet consectet
Lorem ipsum dolor sit amet, consectet adipiscing elit,sed do eiusm por incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis
Ut enim ad minim veniam quis nostrud
Mollit natoque consequat massa quis
Lorem ipsum dolor sit amet, consectet adipiscing elit,sed do eiusm por incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis
Lorem ipsum dolor sit amet consectet
Lorem ipsum dolor sit amet consectet
Lorem ipsum dolor sit amet, consectet adipiscing elit,sed do eiusm por incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis
Mollit natoque consequat massa quis