ISO 13485:2016
The GLOBAL QUALITY MANAGEMENT SYSTEM
New MDR EU 2107/745
The new regulation you have to comply till May 2020
MDSAP
The Medical Device Single Audit Program

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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.

LATEST FROM THE BLOG

PMS, PMCF & PSUR
August 11, 2018   |  (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 7, 2018   |  (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

ISO 14971 Implementation
June 5, 2018   |  (0) Comments

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

Importance of Identification and Traceability
May 10, 2018   |  (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

HOT TOPICS

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

MDR & IVDR

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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MDSAP

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

(Founder)

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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