Döküman Adı Döküman Türü Dil Yayın Tarihi
Infigen Kurumsal Kimlik PDF GB 20/06/2022
2017/745 sayılı Avrupa Parlamentosu ve Konsey Tüzüğü (MDR) PDF TR 05/05/2017
2017/745 sayılı Avrupa Parlamentosu ve Konsey Tüzüğü (MDR) Ekler PDF TR 05/05/2017
MDCG 2022-9 Summary of safety and performance Template PDF EN 05/2022
MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR PDF EN 11/2019
MDCG 2021-24 Guidance on classification of medical devices PDF EN 11/2021
MDCG 2020-13 Clinical evaluation assessment report template PDF EN 07/2020
MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template A guide for manufacturers and notified bodies PDF EN 04/2020
MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template A guide for manufacturers and notified bodies PDF EN 04/2020
MDCG 2019-9 Rev.1Summary of safety and clinical performance A guide for manufacturers and notified bodies PDF EN 03/2022
IMDRF Principles and Practices for the Cybersecurity of Legacy Medical Devices (N70) Final PDF EN 11/04/2023
Software as a Medical Device (SaMD): Key Definitions PDF EN 09/12/2013
Quality Management Systems - Process Validation Guidance PDF EN 02/01/2004
MDCG 2019-8 v2 Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices PDF EN 03/2020
MDCG 2021-11 Guidance on Implant Card – ‘Device types’ PDF EN 02/07/2023
MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software PDF EN 02/07/2023
MDCG 2021-11 Guidance on Implant Card – ‘Device types’ PDF EN 02/07/2023

Tıbbi cihaz sektörü yalnızca sektör deneyimi olanların anlayabileceği ve çözebileceği karmaşık ve zor bir sektördür. Profesyonel danışmanlardan oluşan ekibimiz bu zorlukları derinlemesine ele alarak ürüne özgü çözümler için gerekli beceri ve yeteneğe sahiptir.
Infigen Blog