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Our Services

IEC 60601 Pre-compliance Evaluation

This evaluation is conducted prior submission of the equipment for compliance testing and aims to identify potential.

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ISO 14971 Risk Management


Risk management is an integral part of all phases of the life cycle of a medical device and it's purpose is to address risks associated with a medical device...

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Medical Device Software

IEC 62304 requirements relevant to software development and planning, software maintenance, software risk management, configuration management...

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IEC 62366 Usability Engineering

Manufacturers of medical devices are required to use a process to analyse, specify, develop, and evaluate the usability of a medical device as it relates to safety.

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Project Management


Our expert involvement will be from the start of the project until you receive your desired certification and test reports.

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Compliance Training

Usability engineering training to IEC 60601-1-6 & 62366 and Medical Software training to IEC 62304 are offered.

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601 Consultancy Ltd.

601 consultancy

Safe & Compliant

About Us

601 Consultancy Ltd is a consultancy service provider for Medical Devices manufacturers in the application and implementation of IEC 60601 series of standards. Our experts are well equipped with years of experience gained from working with well-known global test houses assessing medical and laboratory equipment compliance with the relevant standards.

Whether the product is in early or final stages of the design, we can support your team achieving a safe and compliant product including Constructional Safety, Software, Risk Management, Usability, Markings and Documentation requirements.