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 management…..

Hot Topics

CE Marking MDR Transition

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FDA 510(K) Submission

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ISO 13485:2016 Quality Management

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IVDR EU 2017/746 CE Marking

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ISO 14971:2019 Risk Management

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Latest Articles

How to structure Post-Market Process within the Scope of MDR 

The Medical Device Regulation (MDR) 2017/745 has significantly enhanced requirements for post-market surveillance (PMS) to ensure the continuous safety and performance of medical devices in the European Union. Manufacturers must establish a robust post-market process to comply with these regulations, maintain market access, and improve patient outcomes.  The post-market surveillance system shall be suited to …
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Clinical Investigation Under EU 2017/745/ MDR

The European Union’s Medical Device Regulation (MDR) 2017/745 establishes a comprehensive framework for the clinical evaluation of medical devices, ensuring their safety and performance before market introduction. Central to this framework is the categorization of clinical investigations, each serving distinct purposes in the device development lifecycle. The primary types of clinical investigations include Exploratory, Observational, …
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Responsibilities of Economic Operators Under the Medical Device Regulation (MDR)

The European Union’s Medical Device Regulation (MDR), which came into full effect on May 26, 2021, establishes stringent requirements to ensure the safety, performance, and quality of medical devices in the EU market. Economic operators, including manufacturers, authorized representatives, importers, and distributors, play pivotal roles in ensuring compliance. This article explores the responsibilities of these …
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Latest News

EU Adopts New AI Regulation: Harmonizing AI Rules Across Europe
EU Adopts New AI Regulation: Harmonizing AI Rules Across Europe
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Regulation (EU) No 2024/1860 has been published in the Official Journal of the EU
Regulation (EU) No 2024/1860 has been published in the Official Journal of the EU
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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
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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
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The Number of Medical Device Notified Bodies is increasing
The Number of Medical Device Notified Bodies is increasing
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