Medloft Articles

medical device software

Medical Device Software Life Cycle Management

The increased validation requirements of MDR (EU 2017/745) bring new challenges to the manufacturers of devices utilizing a software and standalone software which are considered as medical device in line...

Read More
MDR Clinical Evaluation Requirements

MDR Clinical Evaluation Requirements

MDR Clinical Evaluation Requirements including clinical investigation are defined on Chapter VI, Annex XIV and Annex XV respectively. As you know, to CE Mark a medical device under MDR, the...

Read More
PMCF PMS PSUR

PMCF, PMS and PSUR Requirements

PMCF (Post Market Clinical Follow-Up) is maybe one of the most challenging new MDR (EU 2017/745) requirements. As many of you know, MDR has increased requirements for clinical evaluation and...

Read More
mdr technical documentation

MDR Technical Documentation Requirements

MDR Technical documentation requirements will be one of the main challenges for the medical device manufacturers during transition from 93/42/EEC (MDD) to EU 2017/745 (MDR). As explained on “How to...

Read More
implant card

Implant Card Requirements of MDR

Implant card (IC) is one of the new requirements of the MDR – EU 2017/745. The requirements specified in Article 18 will bring new challenges to the daily life of...

Read More
iso 13485 quality management system

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...

Read More
ISO 14971 Risk Management

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....

Read More