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The Need for ISO 13485 certification for your Medical devices

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The Need for ISO 13485 certification for your Medical devices

The International Standard Organization stated as the ISO 13485 is formulated as the Quality Management System (QMS) for Design and Manufacture of medical devices. The ISO 13485 is a certification provided to the medical device manufacturer and controls in the work to ensure the safety of the product. Global Quality Services (GQS) focuses primarily on auditing the risk management activities involved in the manufacturing activities and the design control activities. The leading consulting firm in India has provided the best ISO certification consultancy for a wide variety of clients across the countries and we will make internal audits on the proper integration of the customer-specific requirements. Since this is related to the medical field, we ensure that the people are highly benefitted without any miscarriages. The other important thing you need to make sure to get this certification is that you need to formulate the best risk management and contingency planning. In addition to this, you need to be able to formulate quality policies and objectives, set up a proper system for maintaining the documentation procedures, records and sustainability.

Who can avail of this?

All the medical design companies, the medical device manufacture companies, and the related industry sector can get this ISO 13485 certification to make their Medical devices approved to be the high standard quality.

The Reason:

The medical device manufacturers must know the reason for availing such cardinal certifications for their medical devices. The reasons include, they will get an opportunity to supply their medical devices for the top-notch industries; they can easily cater to the export market, the safety of the product or the devices will be highly ensured – thereby the people can trust the manufacturer easily, helps them to perform high traceability management, the entire business processes will be streamlined and also helps by improving the efficiency.

The ISO 13485 certification helps the medical device manufacturers in the proceeding of business process optimization. To make your business highly optimized, any manufacturer must focus on some of the mandatory things like – Technology, Re-engineering processes, Training (if needed), Strategic sourcing, supply chain design, Cost reduction, Quality control, High customer satisfaction and most primarily meeting the specific customer requirements. Global Quality Services (GQS), which strives as the best consulting firm for ISO certifications in Bangalore , will put all together and endeavors to make any organization fulfill these business optimization techniques to enhance their business. The medical device manufacturers must make themselves sustainable in the business arena and then they can create a large impact in their field. The highly sustainable business must be very strict in satisfying the needs in all areas like Environmental, Economic, Social, and Governance. Making your business sustainable and optimized will create a high impact among the public. The foremost thing that all manufacturers must keep in mind is the well-being of the public. Hence, make sure that the medical devices that you manufacture are meeting all the specific requirements and Global Quality Services (GQS) will help you by assisting the same.

Contact shakti@gqsindia.com  9845313910  for further information

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India – Bengaluru , Chennai, Hyderabad, Mumbai, Kolkata, Mysore, Belgaum

 

What is new in ISO 13485 with free download

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ISO 13485 Download documents

ISO 13485 Download documents

What is new in ISO 13485 and how can GQS help ?

ISO 13485 training and certification to Achira a medical equipment company in Bangalore has been initiated since May 2018. The process of consultancy involves

  1. Preparation of Medical device file.
  2. ISO 13485 Certification steps
  3. ISO 13485 consultant support for preparation of Medical device file MDF
  4. Writing procedure with respect to Advisory services
  5. Writing procedure for Software validation
  6. What softwares are required to be validated ?
  7. How are the validation protocols to be documented and recorded

Call us to know more about ISO 13485 Consultancy, ISO 13485 Certification and guidelines to prepare Medical device file.

9845313910, 9845078743, drop an email to shakti@gqsindia.com

 

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