Medical Device Testing

Medical Device Testing
Stent

Whether you work for the healthcare industry or not, you must know how recently medical devices have developed. In the current scenario, there is a medical device to carry out a number of tasks in the domain.

These instruments not only increase work efficiency but also provide better overall results. However, the aforementioned evolution also raises the requirement of medical device testing to ensure their safety to be used on humans. Without this testing, the instruments may end up creating a problem for both the professionals and the patients.

Get the Approval for Your Medical Device

It is crucial for every medical device to be checked against the standards specified by the IS and ISO. For this purpose, various tests are run on these instruments to examine any presence of bacteria or other microorganisms that can harm the patient.

The medical device stability testing further helps in getting the approval for the tool from regulatory bodies while making medical device audits stress-free.

Medical Device Testing Services for Patient Safety 

The foremost reason why medical devices are developed is to help out the patients. But this purpose gets failed with negligence in medical device compliance. That is why medical device testing becomes vital, as it checks for the safety of using the instrument on patients for its particular application. 

Medical Device Stability Testing for Approval

Regulatory bodies only approve and provide stamps to the medical devices that follow their compliance regulations. So a manufacturer will only be able to sell their instruments if the authorities allow them, which will not be possible without certification from an accredited medical device testing lab.

Medical Device Testing for Hassle-Free Audits

Official audits are conducted on a regular basis to see whether regulations are followed for all medical devices or not. These audits can be made hassle-free with proper results and documentation of reliable medical device testing services. In case the devices fail under these audits, a heavy penalty has to be paid.

Our Medical Device Testing Services

We are one of the leading medical device testing labs working in the domain for years. Thus, we can offer you a complete solution for all your medical device testing requirements. Some of the services offered by us include:

  • Bio Burden Testing
  • Sterility testing
  • Bacterial Endotoxin
  • Ethylene oxide residue testing as per ISO 10993
  • Stability testing
  • Identification and purity testing of raw materials
  • Environmental monitoring of manufacturing facilities
  • Sealing integrity test for packaging materials
  • Leaching of heavy metals and impurities
  • Organic residues
  • Testing for compliance to various IS and ISO standards
  • Clinical trials including early phase clinical development
  • Toxicity studies
  • Regulatory support

 

Besides these services routinely offer to the industry, we also specialize in on routine analysis. Drawing on our years of experience with a wide array of analytical techniques, we can help you solve complex analytical challenges by developing and validating custom methods to meet your specific requirements.

Why Choose Us for Medical Device Testing Services?

We offer a comprehensive array of contract research and testing services to the medical device industry. Our team of over 200 skilled professionals backed by state-of-the-art laboratory infrastructure and two NABL accredited laboratories has been working closely with leading players in the medical device industry. Therefore, you can rely on our services and the provided results.

If you want to get your medical devices tested now, you can reach us through the provided ‘Quick Query’ form or directly call us on +91-11-45754575. We will look closely into your requirements and provide you with the most appropriate solution. 

Quick Query
Quick Query

Once you fill out this form, you will:

1. Get an email or phone from our team to understand your exact requirement.
2. After that, a quotation catering to your requirement will be sent to your mail.
3. Once you approve the quotation, you can send us the sample for testing and we would provide you with the test report.

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Send us your requirement and our team of experts will find the best solution for you and send you a proposal free of cost! 

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