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

About Us

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.

Our PIQ Values

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.

Our PIQ Values

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.

Our PIQ Values

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.

Passion

Passion is our Character

Indifference

Indifference

Passion

Passion is our
Character

Integrity

Integrity is our Guide

Falseness

Falseness

Integrity

Integrity is our
Guide

Quality

Quality is our Way

Mediocracy

Mediocracy

Quality

Quality is our
Way

Passion

Passion is our
Character

Integrity

Integrity is our
Guide

Quality

Quality is our
Way

Our Quality Policy

Requalite has implemented a quality and process management system aligned with the ISO 9001 standard with following quality policy elements:

  • Compliance with appropriate regulations, guidelines, and laws
  • the client’s expectations and requirements considering the provided services
  • the continuous improvement of activities of Requalite.

Sunt in culpa qui officia mollit natoque

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

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

Our Quality Objectives

In this respect, Requalite established the following quality objectives within the company:

  • comply with all appropriate standards and legislations
  • develop the staff in the needs and responsibilities of quality management
  • having a customer focused approach in all services
  • ensure that the services are introduced to the highest standards of quality
  • provide a continuous improvement and make best use of the management resources in all quality matters
  • share and implement our quality objectives within the company and to related partners

Ut enim ad minim veniam quis nostrud 

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 adipiscing elit,sed do eiusm por incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis

Our Quality Motto

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.”

Sunt in culpa qui officia mollit natoque

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

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

Regulatory and Clinical Study services for medical Device Compliance in Europe.

Dr. Hakan Inan

Hakan Inan, PhD
Founder & Managing Director
Stanford Medical, LMU-Munich

Founder

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.

Our Team

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.

Our Team

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.

Our Team

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.

Karim Tabiti, PhD

Chief Strategy Officer

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Mustafa Köksal, PhD

Regulatory Affairs Manager

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Anne Ziel, MSc

Clinical Study Specialist

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Gurbet Köse, PhD

Clinical Study Specialist

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Sebnem Döner, PhD

Senior Medical Writer

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Uta Kossatz Boehlert, PhD

Clinical Study Specialist

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Hüseyin Uysal, PhD

Senior Medical Writer

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Shah Rawat, MD PhD

Clinical Study Specialist

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Ömer Kizilirmak

Quality Manager

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.
Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Haluk Sarioglu

Accountant

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Bohris Zhang

Business Development Representative China

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Ayse T. PhD

Clinical Study Manager

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Umit Yasar, MD PhD

Senior Medical Writer

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.
Female Portrait

Kerstin Adolph

Clinical Study Specialist

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Grace Chia, PhD

Senior Medical Writer

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Akari Asogawa

Business Development Representative Japan

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Ari Tokuoka

Business Development Representative Japan

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.
Female Portrait

Eunseo Yi

Business Development Representative Korea

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Dominik F.

Data Protection Officer

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Ömer Kizilirmak

Quality Management Expert

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Mustafa Karasahin

IT Specialist

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Haluk Sarioglu

Accountant

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Mustafa Karasahin

IT Specialist

Sit et debitis adolescens cotidieque, at quo erat mucius quidam. Ius veri soleat ea. Ei quo dicit causae prodesset.

Words from Our Patients