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

Stability Testing

Stability testing is a critical process that ensures product safety, efficacy, and compliance with regulatory standards in medical devices. Under the Medical Device Regulation (MDR), stability testing takes on heightened importance due to its focus on patient safety and rigorous requirements. This article explores into stability testing, its significance, key components, and best practices for …
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MDR Transport Testing

Transport testing, as part of the EU 2017/745 Medical Device Regulation (MDR), is crucial to ensure that medical devices maintain their safety, integrity, and functionality during transportation. Medical devices, which can vary from complex diagnostic devices to small surgical equipment, are often exposed to various stresses during shipping and handling. Therefore, it is essential to …
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The Evolution and Impact of Software as a Medical Device (SaMD) in Healthcare

In recent years, the intersection of technology and healthcare has given rise to a transformative phenomenon – Software as a Medical Device (SaMD). SaMD refers to software intended to be used for medical purposes, without being part of a hardware medical device. This innovative approach to healthcare has reshaped the landscape of medical devices, offering …
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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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