Hi, I’m Rishabh Kumar founder of 60601consult – a leading consulting firm that specializes in helping medical device manufacturers navigate the complex world of regulation.

As an Electronics engineer who worked on IEC 60601 for the last 5 years in the Compliance Testing industry, I experienced firsthand the challenges and frustrations of trying to bring a product to market while adhering to regulations. Determined to make the process easier for others, I founded 60601consult to provide expert guidance and support to medical device manufacturers and educate Labs/Individuals Regarding the Testing of Medical devices.

With a deep understanding of the regulatory landscape, including the requirements of the FDA, EU MDR, CDSCO, and other international bodies, Me and the team at 60601consult help clients develop effective regulatory strategies, prepare and submit necessary documents, and ensure compliance with all regulations.

In addition to regulatory consulting, 60601consult offers a full range of services, including pre-submission guidance, auditing, compliance assessments, and training and education on regulatory requirements.

What sets 60601consult apart is the personalized approach we take with each client, ensuring that they are able to provide the specific services each client needs to bring their innovative medical devices to market with confidence.

Our long-term goal is to help medical device manufacturers to navigate and gain easy access to the market, achieve success, and bring forth the best and most innovative devices to the market as soon as possible.