Medical device testing

To ensure that your product is safe for both patient & operator, we help you with product requirements & safety testing of medical devices and medical equipment.

The process of successfully navigating the complex process of testing and approvals in order to bring new healthcare equipment or medical devices to market can be daunting, particularly for organizations with no prior experience.

You must identify your product as well as the relevant regulatory standards, which often require specific documentation, testing, and reporting that must be done in order to demonstrate device compliance, a necessary step in gaining certification and approval.

This process typically takes months to complete, but can stretch to a year or longer in certain situations. In the end, healthcare and medical device approvals can take a significant toll on internal resources.

Nemko has extensive experience testing many kinds of medical devices. Our testing laboratories feature advanced test equipment that can measure and stress your product to make sure it fulfills all compliance requirements for your planned markets. Our diverse and experienced team brings in-depth knowledge and understanding of various complex medical equipment technologies. The medical device market is expected to grow rapidly soon.

Nemko’s global team pairs years of industry expertise with their state-of-the-art testing facilities throughout America, Europe, and Asia to partner with organizations seeking approvals for their new medical devices in the market.

In India to implement the regulation on medical devices, the CDSCO published two amendments to the 2017 medical device regulation. Both the amendments came into force on 1st April 2020. For all Gazette notifications click here.

For more information about how Nemko can help your organization with medical device testing and certification, contact us or mail us at india@nemko.com or give us a call at +91-9205690574 .

Nemko electrical medical device testing services

Nemko electrical medical device testing services offering unmatched support in the field of testing, inspection, and certification, Nemko can confidently guide your organization through the complex certification and approvals process with ease.

Choosing Nemko as partner will reduce cost and time to markets. Nemko test reports and certificates are recognized and accepted for national approval applications.

Optimising the approval process

You get test reports according to international standards for safety, EMC, telecom and environmental requirements to demonstrate conformity with national requirements.

We perform quality management audits as joint audits for several countries.

We are your local partner

By contacting your local Nemko team you get access to our experts. They are handling your projects and following up the delivery. Nemko has test facilities for healthcare equipment in America, Europe and Asia.

IEC 60601-1 (General requirements for safety), IEC 60601-1-xx (Collateral) and IEC / ISO 60601-2-xx / 80601-2-xx (Particular) series of standards. Nemko can assist you to ensure product compliance within more than 50 Particular standards
CB certificates , 52 participating countries
EMC and telecom testing
RoHS testing
Reach and WEEE services
Climatic and environmental testing

Nemko advisory services

Your local Nemko team of experts will handle projects through every step of the process and follow up on delivery, keeping your team apprised of any regulatory changes that may occur in the future.

Early contact with our experts for pre-compliance evaluation
Establishing a test plan based on your market plan
Consider regulatory changes in near future

10 Steps for achieving medical device approvalYou have a new and innovative medical device that you believe can have a major impact on the health and wellbeing of millions of people. But to successfully bring your device to market, you must ... Know More

Avoid Frustrating DelaysWatch out for these common pitfalls that can occur during the electrical medical device approval process. Read more about Avoid Frustrating Delays

Your documentation checklist: getting it right the first timeDocumentation is a critical element in the regulatory review and approval process for medical devices. Yet, product development teams often fail to understand regulatory requirements regarding ... See how it works

Robot for hospitalised children gains Nemko certification

A remotely operated robot that becomes the classroom ‘eyes and ears’ of children with long-term illness was developed by the Norwegian company No Isolation, which relied on Nemko for testing, inspection and certification services.

on-demand webinar introduction to requirements for medical devices

By watching the webinar, you will get a better overview of the IEC 60601 series, its constituents and the main elements of risk management under ISO 14971.

Watch our on-demand medical device webinar

Medical device testing

Related pages

Robot for hospitalised children gains Nemko certification

on-demand webinar introduction to requirements for medical devices