Your Partner for Quality and Regulatory Compliance

in MEDICAL DEVICE INDUSTRY

With 15+ years experience we are constantly working for better service...

Our Services

consultancy_01

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

audit

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

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During Covid 19 we offer remote in house training courses to improve staff knowledge, competency and regulatory skills…

design

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

Hot Topics

The new date of application of MDR is 26 May 2021. If you plan to CE Mark your medical device or prepare for MDR transition, this “How to?” article maybe useful for you…

Premarket notification process, known as a 510 K submission, is required for Class II devices to enter the US Medical Device Market…

This 2016 revision of the standard provides a basis for the quality management system in parallel to the EU MDR  and other international regulatory changes…

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