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Prove that your medical devices are working right

ISO 13485 is a certification that sets forth the standard of medical devices. Safety and quality assurance is important, especially in the case of medical equipments. To that end, prove that your medical devices fall upon the right standards with ISO-13485 certification.

Price Starts RS @ 14,999 /-

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ISO 13485 Certification Process

Step 1
Documentation
Step 2
Application Filling
Step 3
Application Assement
Step 4
Grant Of ISO 13485 Certification

What is ISO 13485 Certification in India?

ISO 13485 Certification

When it comes to medical devices, if there are two things that are not compromise-able here, they are:

  1. The quality of the medical device
  2. The safety when you are using such devices.

Therefore, the regulatory standards that are set forth for such devices are especially stringent and these standards are needed to be followed through the entire life cycle of the medical device. This is not a matter of the eight quality either, many organization need to demonstrate that they can handle the quality management of their medical equipment. This demonstration comes in the form of ISO -13485:2016 certifications.

ISO-13485 sets the standards in regards to the quality management system associated with the medical devices industry.

If you want this certification, you should get in touch with Registrationwala and you can begin with the applying for the certification.

Benefits of ISO 13485:2016

  1. The quality of the medical equipments is managed at the best level.
  2. With this certification, you can gather the trust of medical industries.
  3. The company’s credibility and image will improve
  4. The customer satisfaction will improve as well.
  5. The process of quality management for the medical devices is further improved. 
  6. The employees are going to look forward to continually improving themselves.

Eligibility Criteria for ISO 13485 Certification in India

Before applying for ISO 13485 Certification, you must adhere to the points specified ISO 13485 standards. For that purpose, you need to train your organization as per this standard.

Eligibility Criteria for ISO 13485 Certification in India

Before applying for ISO 13485 Certification, you must adhere to the points specified ISO 13485 standards. For that purpose, you need to train your organization as per this standard.

Process of obtaining the ISO 13485 Certification in India

  1. Gathering the documents
  2. Submitting the application for ISO 13485 Certification
  3. Letting the application and the procedure document be assessed by an auditor
  4. Obtain the Certification if the auditor agrees

Registrationwala will assist you through the filing and the registration process and providing you the certification.

Our Assistance to get the ISO 13485 Certification in India

 Registrationwala can assist you with the registration by providing you the following services:

1.    Selection of certification type

2.    Document aggregation

3.    Draft approval

4.    ISO 13485 Certification.

Improve the energy efficiency of your business. Show that your medical devices work right and as per the standard by getting ISO 13485 Certification with the aid of Registrationwala.

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