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Hot Topics
The new date of application of MDR is 26 May 2021. If you plan to CE Mark your medical device or prepare for MDR transition, this “How to?” article maybe useful for you…
Premarket notification process, known as a 510 K submission, is required for Class II devices to enter the US Medical Device Market…
This 2016 revision of the standard provides a basis for the quality management system in parallel to the EU MDR and other international regulatory changes…
The implementation of the ISO 14971 standard by the manufacturer is the most appropriate solution to ensure the requirements for risk management…
Latest News
Surgical Mask – FDA Issues Umbrella EUA
On August 5, 2020, the FDA issued an umbrella emergency use authorization (EUA) for certain disposable, single-use surgical masks in response to concerns relating to insufficient supply and availability of such masks. This EUA authorizes the emergency use of surgical masks that meet certain performance requirements for use in healthcare settings by health care personnel […]
Software Guidance for MDR & IVDR
The EU Commission has issued a new guidance document for use with the EU 2017/745 MDR and EU 2017/746 IVDR.This document, MDCG 2019-11, contains information on the qualification and classification of medical device software.You can reach MDCG 2019-11 from this link. Share on facebook Facebook Share on twitter Twitter Share on linkedin LinkedIn Share on […]
The Number of Notified Bodies is increasing
The Number of Notified Bodies is Increasing The EU Commission has authorized today the first notified body for the EU IVDR 2017/746 after the 5 notified bodies which were authorized for the EU MDR 2017/745. With 7 months till the date of the application of MDR, 5 organizations started the certification process. Although the EU […]
MDCG 2019-10 Article 120 Guidance
MDCG 2019-10 Article 120 Guidance The guidance document for the implementation of Article 120, which many companies plan to use during the transition to MDR EU 2017/745, has been published. The main requirements for the validity of the 93/42/EEC and 90/385/EEC certificates after May 2021 can be summarised as; No significant changes on the device […]
Latest Articles
ISO 14971 Risk Management Process
The ISO 14971 Risk Management standard defines principles for a risk management process of medical devices. The requirements given in this standard help manufacturers to comply with the main regulations. So, by implementing an ISO 14971 Risk Management Process you can have a big step in your EU MDR, IVDR or FDA certification route. The […]
ISO 13485 Quality Management System
ISO 13485:2016 is a quality management standard for medical devices. This standard provides a basis for the quality management system in parallel to the EU MDR and other international regulatory changes which occurred since the second revision of the standard. On the other hand, this 2016 revision brought requirements closer to the US FDA expectations, […]
EU Medical Device Regulation – How to CE Mark a Medical Device ?
CE mark is required for each medical device sold in EU. Due to the Covid-19 pandemic the date of application of the new EU medical device regulation (EU 2017/745) has been postponed to 26th May 2021. Until this date, Medical Device Directive 93/42/EEC may be still used for the initial certification. A medical device which […]
US FDA 510 K Submission – How to prepare a 510 K File?
Food and Drug Administration (FDA) is the legal authority to establish rules and regulation for the use of medical devices within the United States. According to Food, Drug, and Cosmetic Act products falling within the scope of medical devices, shall be registered in FDA database. In that sense, FDA 510 K clearance is required for […]