OUR SERVICES
New Criteria Consulting focuses on the Medical Device and In-vitro Diagnostic Device Sector and aims to aid manufacturers and distributors to enter or maintain their presence in the “European Market” by ensuring their adaptation to the new European Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). After the adaptation of MDR and IVDR, the manufacturers are now required to act under the guidelines of these two regulations in order to market their products in Europe. With our team of experienced specialists, we guide our customers through their adaptations to the new regulations of the European Union on medical and in vitro diagnostic devices.
Our vision is to understand the needs of our customers and help them achieve their aims in the EU/USA by our dedicated partners and personnel, who would give utmost importance to quality and customer satisfaction.
Our team includes highly-experienced experts in IVDR, MDR, and other regulations with expertise in not only quality management of medical devices and in vitro diagnostic medical devices but also their research & development and manufacturing. Our team members include dynamic experts with PhD degrees from world-renowned institutions in the areas of molecular biology, engineering, microbiology, virology, and biotechnology as well as physicians specializing in biochemistry and pharmacology, and pharmacists, all of whom have extensive experience.
Our services are classified into four categories:
I. Clinical Performance Study Management for In Vitro Diagnostic Devices according to IVDR
· Clinical Performance Study Plan Preparation
Investigator's Brochure Preparation
· Ethics Committee Application
· Competent Authority Application
Clinical Study Design and Management
· Data Evaluation and Statistical Analyses
Clinical Performance Study Report Preparation
II. Clinical Investigation Study Management for Medical Devices according to MDR
· Clinical Investigation Plan Preparation
· Investigator's Brochure Preparation
· Ethics Committee Application
· Competent Authority Application
· Clinical Investigation Study Design and Management
· Data Evaluation and Statistical Analyses
· Clinical Investigation Report Preparation
III. Regulatory Affairs Consulting and Document Preparation (IVDR)
Our IVDR experts at New Criteria Consulting aim to help the manufacturers in their transition to IVDR by the preparation of the necessary documentation for the Performance Evaluation Studies according to the requirements of the IVDR.
· Scientific Validity Reports
· Clinical Performance Study Reports
· Clinical Performance Study Plans
· Investigators Brochure
· Performance Evaluation Plan
· Performance Evaluation Report
· Analytical Performance Report
· Literature Search Plan
· Literature Search Report
· Post-Market Surveillance Plan
· Post-Market Surveillance Report
IV. Regulatory Affairs Consulting and Document Preparation (MDR)
Our experts prepare the following necessary documentation for the Performance Evaluation Studies according to the requirements of the MDR:
· Scientific Validity Report (SVR)
· Investigators Brochure (IB)
· Post-Market Clinical Follow-up Plan (PMCFP)
· Post-Market Clinical Follow-up Report (PMCFR)
· Summary of Safety and Clinical Performance (SSCP)
· Post-Market Surveillance Plan (PMSP)
· Post-Market Surveillance Report (PMSR)
· Periodic Safety Update Plan (PSUP)
· Periodic Safety Update Report (PSUR)
Our vision is to understand the needs of our customers and help them achieve their aims in the EU/USA by our dedicated partners and personnel, who would give utmost importance to quality and customer satisfaction.
Our team includes highly-experienced experts in IVDR, MDR, and other regulations with expertise in not only quality management of medical devices and in vitro diagnostic medical devices but also their research & development and manufacturing. Our team members include dynamic experts with PhD degrees from world-renowned institutions in the areas of molecular biology, engineering, microbiology, virology, and biotechnology as well as physicians specializing in biochemistry and pharmacology, and pharmacists, all of whom have extensive experience.
Our services are classified into four categories:
I. Clinical Performance Study Management for In Vitro Diagnostic Devices according to IVDR
· Clinical Performance Study Plan Preparation
Investigator's Brochure Preparation
· Ethics Committee Application
· Competent Authority Application
Clinical Study Design and Management
· Data Evaluation and Statistical Analyses
Clinical Performance Study Report Preparation
II. Clinical Investigation Study Management for Medical Devices according to MDR
· Clinical Investigation Plan Preparation
· Investigator's Brochure Preparation
· Ethics Committee Application
· Competent Authority Application
· Clinical Investigation Study Design and Management
· Data Evaluation and Statistical Analyses
· Clinical Investigation Report Preparation
III. Regulatory Affairs Consulting and Document Preparation (IVDR)
Our IVDR experts at New Criteria Consulting aim to help the manufacturers in their transition to IVDR by the preparation of the necessary documentation for the Performance Evaluation Studies according to the requirements of the IVDR.
· Scientific Validity Reports
· Clinical Performance Study Reports
· Clinical Performance Study Plans
· Investigators Brochure
· Performance Evaluation Plan
· Performance Evaluation Report
· Analytical Performance Report
· Literature Search Plan
· Literature Search Report
· Post-Market Surveillance Plan
· Post-Market Surveillance Report
IV. Regulatory Affairs Consulting and Document Preparation (MDR)
Our experts prepare the following necessary documentation for the Performance Evaluation Studies according to the requirements of the MDR:
· Scientific Validity Report (SVR)
· Literature Search Plan (LSP)
· Literature Search Report (LSR)
· Clinical Evaluation Plan (CEP)
· Clinical Evaluation Report (CER)· Investigators Brochure (IB)
· Post-Market Clinical Follow-up Plan (PMCFP)
· Post-Market Clinical Follow-up Report (PMCFR)
· Clinical Investigation Plan (CIP)
· Clinical Investigation Report (CIR)· Summary of Safety and Clinical Performance (SSCP)
· Post-Market Surveillance Plan (PMSP)
· Post-Market Surveillance Report (PMSR)
· Periodic Safety Update Plan (PSUP)
· Periodic Safety Update Report (PSUR)
