ISO 13485:2016 has been publishedMedical Device CertificationCMDCAS Program will end beginning of 2019

ISO 13485:2016 has been published

Did you define your transition strategy to ISO 13485: 2016 ? Transition period ends beginnig of 2019... In order to get detailed information about the revised requirements such as Risk Management, Validation, Design and Development, Legal Requirements please contact us

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Medical Device Certification

In order to CE Mark your Medical Device according to European Union Directives and new MDR, IVDR, including FDA 510 K (US), ISO 13485 CMDCAS (Canada) Learn about system and product certification requirements

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CMDCAS Program will end beginning of 2019

Health CANADA has already announced that the CMDCAS program will be stopped at the beginning of 2109. Are you ready for MDSAP ??

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New MDR – Published on 5 May 2017

The new European Medical Devices Regulation (MDR 2017/745) and the In vitro Diagnostic Regulation (IVDR 2017/746) have been published in the Official Journal of the European Union on 5 May 2017. The Regulations will enter into force on May 26th, and the transition period will officially start. The MDR will replace 93/42/EEC and 90/385EC, whereas 2017/746 will be replacing the IVD directive 98/79/EC.  For details of the transition process and further questions regarding the new Medical Device Regulations and IVD Regulations, please contact us… 

ConsulTeam Medical with over 15 years of experience in the medical device sector, provides consultancy services for regulatory, technical and compliance challenges to enable your medical device to enter the global marketplace. With its expert staff, ConsulTeam Medical has been serving its customers during the complete medical device lifecycle starting from design and development, with its customer focused processes.

Under today’s market competition manufacturers are required to launch safe products with low costs. Consulteam Medical with its expert staff is serving the medical device manufacturers and distributors especially within European Union, United States and Canada, among many others like Australia and South American countries. To certify your products in accordance with the relevant standards and regulations, or to establish a quality management system, you can contact us…

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About Us

ConsulTeam Medical with over 15 years of experience and expert staff provides consultancy services to its customers in order to establish effective systems and safe products in line with its quality policy. Please contact  our experts to get detailed information about our services.

       We are committed to

to provide to our customers value added services for the improvement and effectiveness of their organizational structure, quality management system, product and patient safety and regulatory compliance. We work continuously to improve our internal processes, in order to carry out our activities beyond the desired level of service quality and to take all necessary measures for the security of our clients’ information during our work

               in line with our quality policy

Latest News

New EU MDR has been puplished (UAV) The new MDR 2017/745 and 2017/746which will replace 3 medical device directives has been puplished..

Are you ready for the Unannounced Audits? (UAV). UAV’s have been started parallel to the EU recommendation (2013/473/EU)

Meddev 2.7.1 Rev 4 new guidance document has been puplished…

ISO 13485:2016 has been puplished!!!!

Useful Links

ISO Standards

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EU Commission

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US FDA

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Health Canada

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