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ISO 13485 Certification Medical Devices-Quality Management System

ISO 13485 Certification Quality Management System for Medical Devices

Guarantee your medical device equipment and product safety to safeguard public health by achieving ISO 13485 Certification in India.

What is ISO 13485 Certification?

ISO 13485 Certification provides a complete framework for medical device manufacturers, suppliers, or any other external party related to medical devices to ensure product quality and regulatory compliance with the standard.

ISO 13485:2016 Certification is vital for medical device organizations to demonstrate compliance with regulatory requirements so-called law of the land. In the life and health sciences industry, quality management is a multidimensional and non-negotiable issue, covering more than just verification that a finished product meets certain expectations and is safe for use. As a component of the regulatory ISO 13485 standard, a quality management system requires a systematic process for controlling, monitoring, and verifying, analyzing, and improving any activity or process that could affect product conformance. From the manufacturing floor to the end-user the medical devices should be aligned as per the guidelines of the standard. This helps in providing quality products and devices for the consumers.

The International Organization for Standardization (ISO) developed ISO 13485 standard with a revised version in the year 2016 from ISO 13485:2012. Although ISO 13485:2016 standard is based on ISO 9001, (though ISO 13485:2016 is not based on the Annex SL High Level Structure) incorporating the majority of the same requirements, it requires additional controls which include regards to documentation, validation, verification, and identification of regulatory requirements, Increased focus on risk management, Coordination with global regulatory requirements.ISO 13485 Medical Device Quality Management System MDQMS certification focuses on the capability and reliability of your quality, and degree of effectiveness in the areas of design, development, production, and customer care of medical devices and equipment. There is no compromise when it comes to defective devices. The motto of this standard ISO 13485 is to facilitate harmonized quality management system requirements for the medical devices sector.

Benefits of ISO 13485 Certification

Improve the credibility of your organization by providing health safety by achieving ISO 13485 Certification. Other benefits are:

  1. Improve the process of production
  2. Ensures safety in medical devices.
  3. Reduces operational cost.
  4. Continuous Improvement in medical devices
  5. The innate trust of stakeholders and customers
  6. Validate customer satisfaction and wellbeing.
  7. Encouragement of staff and employee training in medical service providers.
  8. Helps in CE Marking of Medical equipment
  9. Extensive market access approval

Requirements of ISO 13485 Certification

Requirements of ISO 13485 apply to medical devices, the requirements apply equally to associated services as supplied by the organization. ISO 13485:2016 set down requirements for a Quality Management System to medical device equipment and related services such as;

  • Identify and adopt a risk management approach to product development and product realization
  • Creation of QMS Manual, Processes, Procedures, Formats/Records
  • Creation of Medical Device Master File
  • Analysis of the validation of processes and procedure
  • Compliance with Regulatory requirements and guidelines of the standard
  • Proper maintenance, control, and repair of medical devices
  • Effective and quick product traceability and recall systems in case of any errors
  • Enhancement and continual improvement in technology
  • An Internal Audit of the organization
ISO 13485 Certification process

Strength of Ascent WORLD

  • We Ascent have our team of Consultants and Auditors with a professional attitude to conduct ISO 13485 Certification process for your organization.
  • We Ascent have experience of 10+years in providing training and knowledge to achieve ISO 13485 certificate in India.
  • We Ascent follow the processes to add value at every stage, by reducing the non-conformities of ISO 13485 Certification.
  • We Ascent provide you with the best quote to value for money-including internal and external audit costs, with no extra cost.
  • Ascent WORLD is available to help you 24X7 to solve your queries.
  • We Ascent in Plan-Do-Check-Act to remove hindrances in achieving the ISO 13485 Certification.
  • We Ascent follow all the ethics to frame the outline that suits your needs and helps in achieving desired results.

Frequently Asked Question

Why you need ISO 13485 Certification in India?

After achieving ISO 13485 Certification you guarantee by your end that the medical equipment has passed all the guidelines and requirements of the ISO 13485 Certification.

Which Organization needs ISO 13485 Certification?

ISO 13485 contains requirements for compliance with the standard that are essential for any organization operating at the manufacturer level, supplier level, or any tier in the medical equipment and pharmaceutical supply chain.

What is the cost of applying for ISO 13485 certification in India?

The cost of this standard is apparently a little higher than the cost of other standards related to quality management as it is a very crucial standard dealing with the safety of medical devices and consumers’ life. It depends on the type of device you are dealing with.

IS ISO 13485 certification mandatory?

ISO 13485 certification is mandatory in some countries for some of the kinds of products being dealt with by some companies types. But obtaining ISO 13485 is safer to deal with medical products as the products are related to health concerns.

How long ISO 13485 certification valid for?

ISO 13485 certification is reviewed for a timeline of 3 years. When an ISO standard is up for revision, they generally announce well in advance and require a technical committee to work on it.

How long does it take to acquire ISO 13485 certification?

Depending upon the strength of an organization it approximately takes 3-6 months for documentation, implementation, auditing, and achieving the certification.

What is the difference between ISO 9001 and ISO 13485?

ISO 9001certification is an international standard for Quality Management systems for all types of industries whereas ISO 13485 certification is a Quality Management System for medical devices.

What are class 1, 2, 3 medical devices?

Medical devices according to FDA or as per EU Regulations are divide into various Categories based on Product Risks ex. CAT 1 / CLASS I (Devices with low-moderate risk to the consumer requires general control; CAT 2 / Class II (Devices with moderate-high risk requires special controls); CAT 3 / Class III( Device with high risk supporting life or sustaining life).

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