Your Partner For Quality and Regulatory Compliance in Medical Device Industry

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 management…..

Hot Topics

CE Marking MDR Transition

FDA 510(K) Submission

ISO 13485:2016 Quality Management

IVDR EU 2017/746 CE Marking

ISO 14971:2019 Risk Management

Latest Articles

MDR Trend Reporting

In the ever-evolving field of medical device regulation, the Medical Device Regulation (MDR) has introduced significant changes to enhance transparency, safety, and traceability. One crucial aspect of MDR compliance is Trend Reporting, a mechanism designed to identify and address emerging issues related to medical devices. This article delves into the intricacies of MDR Trend Reporting, …
1 mins read

Medical Device Sterilization Methods and Validation Process

Manufacturers must determine the appropriate sterilization method to use for their medical device. There are two factors to determine the sterilization method. The first factor is whether the manufacturer will deliver the device as sterile, or the end user will sterilize the device. If the end user is responsible for sterilizing the device, the most …
1 mins read

MDCG 2020-5 Clinical Evaluation – Equivalence

MDCG 2020-5, issued by the European Commission (EC), is a guide that explains how to show that a medical device is equivalent to another with a CE mark. This guide is very important because proving equivalence in the EU is complex. Moreover, the EU MDR and MEDDEV 2.7/1 Rev. 4, a guide on clinical evaluation, …
1 mins read

Latest News

FDA Issues Quality Management System Regulation: Final Rule Amending the Quality System Regulation
FDA Issues Quality Management System Regulation: Final Rule Amending the Quality System Regulation
Proposal for transitional provisions for certain in vitro diagnostic medical devices under Regulation (EU) 2017/746
Proposal for transitional provisions for certain in vitro diagnostic medical devices under Regulation (EU) 2017/746
The Number of Medical Device Notified Bodies is increasing
The Number of Medical Device Notified Bodies is increasing
The official text of MDR extension has been published
The official text of MDR extension has been published
MDCG 2023-3 Guidance has been published
MDCG 2023-3 Guidance has been published
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