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 firstname.lastname@example.org 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
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.