Medical Device Usability: Guidelines and Expectations

Vantage MedTech is a leading provider in the field of electromechanical medical device development, design, and manufacturing. The company ensures that all devices it produces are up to standard and ready to be safely adopted by practitioners and patients alike.

One of the key aspects of Vantage MedTech's approach is its focus on usability. By working closely with the company's development teams, clients can gain expert insight into the usability of medical devices. Vantage MedTech incorporates usability testing and standards into every phase of medical device product development, ensuring that devices are user-friendly and safe.

Vantage MedTech's robust services ensure that medical devices reach the market faster, free of design errors. The company's end-to-end medical device development support includes considering regulatory affairs at each stage of the device's development cycle.

Compliance with various regulations is a top priority for Vantage MedTech. During production and usability testing, the company maintains compliance with international standards such as IEC 62366, IEC 60601-1-6, ISO 13485, ISO 9001, ISO 14971, as well as regional regulations like the FDA, MDD, and MDR.

The importance of usability engineering in medical devices cannot be overstated. The most important international standard for human factors engineering and safety risk management in medical devices is ISO 14971. This standard defines the process for risk management throughout the entire product lifecycle, including identification, assessment, control, and monitoring of risks. IEC 62366-1 specifically addresses usability engineering methods to identify and mitigate usability risks in medical devices.

Failure in usability testing can delay the development timeline, requiring reconfiguration and additional testing. By focusing on usability from the outset, Vantage MedTech helps to minimise these risks and ensure a smoother development process.

In summary, Vantage MedTech is a trusted provider for medical device development, design, and manufacturing. The company's focus on usability, robust services, and compliance with international standards make it a valuable partner for any organisation looking to bring safe and effective medical devices to market.