Emergencies:

(617)-350-2714

Address

920 Aspen Court, Boston 

Clinic Hours:

9:00am – 5:00pm (Mon-Fri) 

Clinic Number

(857)-200-1031

Emergencies:

(617)-350-2714

Clinical Study Services

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.

Services and Treatments

Clinical Investigation

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.

 

What do we offer?

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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.

For more reach out to us click here!

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Clinical Performance Studies

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.

Post-Market Surveillance

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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).

What do we offer?

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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.

For more reach out to us click here!

R&D Studies

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.

What do we offer?

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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.

For more reach out to us click here!

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

What do we offer?

  • Site Identification and initiation
  • Creating of Investigator’s Brochure
  • Designing of the Study and Synopsis
  • Writing of Study Protocol
  • Site Monitoring
  • Data management including EDC
  • Biostatistics
  • Site close out
  • Clinical Study Report
  • TMF and ISF preparation
  • Document archiving

 

For more reach out to us click here!

Post-Market Surveillance

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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).

What do we offer?

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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.

For more reach out to us click here!

What do we offer?

  • Site Identification and initiation
  • Creating of Investigator’s Brochure
  • Designing of the Study and Synopsis
  • Writing of Study Protocol
  • Site Monitoring
  • Data management including EDC
  • Biostatistics
  • Site close out
  • Clinical Study Report
  • TMF and ISF preparation
  • Document archiving

For more reach out to us click here!

Lorem ipsum dolor sit amet consectet 

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Ut enim ad minim veniam quis nostrud 

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Paediatric Care

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Maternal Health

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Minor Surgery

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Important Patient Information

Appointments

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New Patients

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Home Visits

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Prescriptions

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Disability Access

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Emergencies

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Cancellations

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Insurence and Fees

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Online Consultations

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Confidentiality

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