Your Partner For Quality and Regulatory Compliance in Medical Device Industry

About us

With 20+ years experience, we are constantly working for better service…

Our Services

Consultancy

Whether you are a small start-up, requiring an effective regulatory watch or a mature company looking for details.

In House Training

We offer remote in-house training courses to improve staff knowledge, competency and regulatory skills…

Audit

On-site and remote audit services are ideal for having a final review of your technical files or QMS before the certification audit.

Design Control

Medloft helps you ensure that your medical device complies with the applicable standards and regulatory requirements…..

Software Validation

Support you with our experienced team for compliance of your active medical devices which are driven by software or are standalone software

Risk Management

The implementation of the ISO 14971 standard by the manufacturer is the most appropriate solution to ensure the requirements for risk 0management…..

Hot Topics

CE Marking MDR Transition

View Article

FDA 510(K) Submission

View Article

ISO 13485:2016 Quality Management

View Article

IVDR EU 2017/746 CE Marking

View Article

ISO 14971:2019 Risk Management

View Article

Latest Articles

EU Medical Device Regulation – How to CE Mark a Medical Device?

CE mark is required for each medical device sold in EU. Since 26th May 2021 all new devices put on the market shall comply with the applicable requirements of EU medical device regulation. Although the transitional period can be used for current MDD certificates for Class III, Class IIb and Class IIa until 2024 and …
1 mins read
Read More

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 CE Mark your medical device” article, preparation of the technical file is a critical milestone. Since there is no grandfathering for the devices on the …
1 mins read
Read More

IVDR EU 2017/746 CE Marking

The change journey of the EU medical device directives since 2012 was completed on 5 May 2017 with the publication of EU 2017/745 and EU/2017/746 in the EU official journal. EU 2017/746, which we are accustomed to briefly refer to as IVDR, entered into force on 26 May 2022. However, due to the COVID 19 …
1 mins read
Read More

Latest News

The Number of Medical Device Notified Bodies is increasing
The Number of Medical Device Notified Bodies is increasing
Read more
The official text of MDR extension has been published
The official text of MDR extension has been published
Read more
MDCG 2023-3 Guidance has been published
MDCG 2023-3 Guidance has been published
Read more
Transitional provisions for certain in vitro diagnostic medical devices (IVDR 2017/746)
Transitional provisions for certain in vitro diagnostic medical devices (IVDR 2017/746)
Read more
MDCG 2020-21 PSUR Guidance has been published
MDCG 2020-21 PSUR Guidance has been published
Read more
previous arrow
next arrow

How can we help you?

Contact Us!