ISO 13485:2016
MDR EU 2017/745
New Date of Application 26 May 2021
The Medical Device Single Audit Program


With 15+ Years Experience we are constantly working for better service

With 15+ years experience ConsulTeam Medical is your global regulatory and quality partner. Focused in medical devices and in-vitro diagnostics, ConsulTeam Medical provides you on time services required to bring your product on the market.


ISO 14971 Implementation
January 2, 2020   |  (0) Comments

Risk Management Principles for Medical Devices (ISO 14971:2019) The ISO 13485 standard stipulates risk management practices for all product realization processes in Section 7.1… Read More

October 17, 2019   |  (0) Comments

New requirements for post market surveillance for Medical Devices. How to interpret the Annex III of the EU 2017/745(MDR) and EU 2017/746 (IVDR) Post… Read More

Clinical Evaluation
July 28, 2019   |  (0) Comments

Clinical Evaluation: New requirements for the clinical evaluation of medical devices. How to interpret the Meddev 2.7.1 Rev 4 and Annex XIV of the… Read More

Importance of Identification and Traceability
May 10, 2019   |  (0) Comments

The ISO 13485 standard places great emphasis on identification and traceability throughout the product realization process so that "product safety" can be fully achieved.… Read More


ISO 13485:2016

The 3rd revision of ISO 13485 enhances in particular requirements for validation, risk management, compliance with legal requirements

Quality Management

This revision of the standard provides a basis for the quality management system in parallel to the EU MDR’s and other international regulatory changes which occurred since the second revision of the standard

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CE Marking

The new EU Medical Device Regulations EU 2017/745 and EU 2017/746


New CE Marking requirements for your medical device.

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FDA 510 K

Your roadmap to enter US Market

USA Market

FDA defines the requirements for entering the US Market

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Medical Device Single Audit Program, which will enable you to enter multiple markets

Canadian Market

Health Canada has announced that MDSAP will be replacing CMDCAS program from the beginning of 2019

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Our Team

Osman Dursun


Osman is a graduate of Bogazici University Physics Department and has over 20 years experience in medical devices. Since 2003 he has been working as…

Mustafa Kahvecioglu

(Quality & Technical Expert)

Mustafa has a bachelor’s degree from Istanbul Technical University (ITU) Metallurgical Engineering Department. He joined ConsulTeam Medical in 2016 with 30 years of experience in…

Gozde Oz

(Quality & Technical Expert)

Gözde is a graduate of Çankaya University, Department of Industrial Engineering. She has international company experience in the field of Quality Assurance & Regulatory Affairs…

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