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 is a medical device Regulatory Affairs and Clinical Study services company located at the heart of Europe, in Munich-Germany. We provide full CRO services for Clinical Studies and technical support to manufacturers of medical devices in accordance with EU regulations of MDR and IVDR. We consult manufacturers of in vitro diagnostic and medical devices on the planning, preparation, execution, and reporting of all required technical documentation for existing as well as novel devices to obtain CE-marking.
At Requalite we strongly believe the value of PIQ, which is of three main pillars of our work ethics and strictly implement them in every aspect of our business and personal interactions with our clients as well as within our company.
At Requalite we strongly believe the value of PIQ, which is of three main pillars of our work ethics and strictly implement them in every aspect of our business and personal interactions with our clients as well as within our company.
At Requalite we strongly believe the value of PIQ, which is of three main pillars of our work ethics and strictly implement them in every aspect of our business and personal interactions with our clients as well as within our company.
Requalite has implemented a quality and process management system aligned with the ISO 9001 standard with following quality policy elements:
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In this respect, Requalite established the following quality objectives within the company:
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Our quality motto is: “At every level of organization, our company is fully committed to service excellence, client satisfaction, and the progress of healthcare for the good of society. “ Requalite is determined to help device manufacturers to produce better performing and safe medical devices to improve patients health.”
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Regulatory and Clinical Study services for medical Device Compliance in Europe.
Dr. Hakan Inan
Dr Hakan Inan is the Founder and Managing Director of Requalite. He is also contributing and guiding the technical projects. He obtained his PhD at Nanotechnology and has strong research experience in In Vitro Diagnostic device and assay development for Cancer applications. His scientific expertise is in the field of Hematology, Immunology, and Oncology. He accumulated years of scientific and research experience as a PhD student and Postdoc at Stanford (Cancer Early Detection Center) and at LMU-Munich.
Requalite is proud to be house of technical experts with strong scientific background in medical devices and in vitro diagnostics. All our medical writers have PhD degree and possess profound research experience in medical and scientific fields including Molecular Biology, Genetics, Nanotechnology, Immunology, Oncology, Haematology, Cardiovascular diseases, Neurology, and Enzymology. All technical experts have gone thru intensive IVDR training program.
We are bringing together an international team of experts who had performed research in some of the world’s best universities, such as Stanford, LMU-Munich, Purdue, UPenn, Karolinska, Columbia, Heidelberg University, UMG Göttingen, University of Hamburg, and Max Planck Institute.
Requalite is proud to be house of technical experts with strong scientific background in medical devices and in vitro diagnostics. All our medical writers have PhD degree and possess profound research experience in medical and scientific fields including Molecular Biology, Genetics, Nanotechnology, Immunology, Oncology, Haematology, Cardiovascular diseases, Neurology, and Enzymology. All technical experts have gone thru intensive IVDR training program.
We are bringing together an international team of experts who had performed research in some of the world’s best universities, such as Stanford, LMU-Munich, Purdue, UPenn, Karolinska, Columbia, Heidelberg University, UMG Göttingen, University of Hamburg, and Max Planck Institute.
Requalite is proud to be house of technical experts with strong scientific background in medical devices and in vitro diagnostics. All our medical writers have PhD degree and possess profound research experience in medical and scientific fields including Molecular Biology, Genetics, Nanotechnology, Immunology, Oncology, Haematology, Cardiovascular diseases, Neurology, and Enzymology. All technical experts have gone thru intensive IVDR training program.
We are bringing together an international team of experts who had performed research in some of the world’s best universities, such as Stanford, LMU-Munich, Purdue, UPenn, Karolinska, Columbia, Heidelberg University, UMG Göttingen, University of Hamburg, and Max Planck Institute.
Clinical Study Manager
Regulatory Affairs Manager
Clinical Study Specialist
Clinical Study Specialist
Senior Medical Writer
Clinical Study Specialist
Medical Writer
Medical Writer
Quality Management Expert
IT Specialist
Accountant
IT Specialist
Quality Management Expert
IT Specialist
Accountant
IT Specialist