ISO 13485 Certification: Quality Management System for Medical Devices

Improve the quality of your Medical Devices by achieving ISO 13485 Certification in Maldives and Male.

What is ISO 13485 Certification?

Medical devices are one of the critical devices as it is directly related to the health of the user. It is the most regulated verticals in the world. By following stringent requirements, device quality must satisfy the need of the user or customer as well as meet the regulatory requirements before placing them in the market.

This standard is a guideline for quality business practices specifically it focuses on organizations’ quality management systems (QMS) in relation to medical devices or related services. The ISO 13485 standard specifies the requirements to develop and maintain the quality of the devices as per technology update and techniques. It systematizes processes that may already meet the comprehensive requirements for a QMS in the medical device industry. Adopting ISO 13485 Standard helps to accomplish and implement the practical foundation for the manufacturers that the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, consistently meet regulatory requirements associated with the organization.

The ISO 13485:2016 standard aligns with the older version of ISO 9001 i.e. ISO 9001:2008. ISO 13485 standard is the parallel standard with the purpose to maintain Quality Management System for Medical Devices. This standard aligns with the requirements of the three EU directives for medical devices (EU directive 90/385/EEC, EU directive 93/42/EEC, and EU directive 98/79/EC). Implementation of these Directives helps an organization to conduct its operation as per the compliance requirements.

The new version of EN ISO 13485 Certification in May 2017, suppresses the old Directives, with closer alignment with the EU MDR.

Benefits of ISO 13485 Certification

Achieving ISO 13485 Certification helps an organization in the long run in the following ways:

  1. Product Improvement
  2. In avoiding recalls and errors
  3. Helps in improving test and business performance
  4. Provides commitment to customers for the quality
  5. Improve access to the worldwide market with ISO 13485Certification
  6. Meet customers’ expectations
  7. Helps to compliance regulatory requirements
  8. Usage of updated technology
  9. Enhance marketability and creditability
  10. Provide confidence and improve the morale of the employees

Why you need ISO 13485 Certification?

Achieving an ISO 13485 certification has significant benefits to the organization as well as to the customers. It systematizes processes mitigates risk by ensuring your product quality. ISO 13485 Certification is the common path to meeting requirements to market and sell your device worldwide. With a proper system in place and along with the certification, assurance can be provided that the organization is able to provide medical devices & related services that consistently meet customer expectations and regulatory requirements.

Requirements of ISO 13485 Certification

ISO 13485:2016 specifies requirements for a Quality Management System for Medical Devices to meet customer and applicable regulatory requirements.ISO 134845 Certificate helps an organization to apply requirements equally to associated services supplied by the organization.

  • Maintain the requirements for the Quality Manual, Control of Documents, and Control of Records for effective QMS
  • Develop plans and policies to implement ISO 13485 standard in an organization
  • Control and develop all resources, including human resources, buildings, and infrastructure
  • Establish product requirements review to monitor and measure the product or service.
  • Evaluate performance with continual improvement in QMS for Medical Devices
  • Conduct Internal Audit

Which Organization needs ISO 13485 Certification?

It can be used by an organization involved in one or more stages of the life cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support). The requirements in this standard can also be used by suppliers or other external parties providing products (e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations can also use the requirements in this International Standard.

ISO 13485 Certification process in Maldives and Male

Strength of Ascent MALDIVES

  • We at Ascent MALDIVES have helped over 6000 management systems to put their business in the place.
  • We at Ascent have been serving in this field of Management Systems Standards, Product Marking Certifications, and Training for more than 10+ years with vast knowledge of the ISO compliance standards.
  • We have well-qualified professional and competent Consultants who understand your business and technical needs and can help you with the practical and pragmatic approach in developing ISO 13485 Certification standard requirements and Certification with proper guidance and training of your personnel.
  • Over the years with this approach, we have been enjoying the positive market value that has helped us win numerous service awards and helps in gaining the trust of our clients and customers.
  • We at Ascent do not mislead you with any hidden charges.
  • We provide the best quote that suits your pocket and achieves excellence in your work.
  • We at Ascent enjoy a 100% success rate with certifications and audits.
  • We Ascent are THE BEST.

Email your business information to or make an appointment for a meeting. After evaluating your business we will get you the real cost, involvement patterns, and timelines, for implementing and acquiring ISO 13485 Certification.

Frequently Asked Questions

What is the cost of applying for ISO 13485 Certification in the Maldives?

The cost of this standard is 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 and the need to acquire Certification.

IS ISO 13485 Certification mandatory?

ISO 13485 certification is mandatory in some countries for some of the kinds of products. Nevertheless, obtaining ISO 13485 Certificate is safer and effective to deal with medical products.

How long does it take to acquire ISO 13485 Certification?

Depending upon the strength of an organization it approximately takes 3-6 months for companies.

What is the validity of the ISO 13485 certificate?

ISO 13485 certification is valid for 2 (Three) years from the date of issue of the certificate, subject to a successful annual surveillance audit at the end of the first and second year.

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).

What is the difference between ISO 9001 and ISO 13485?

ISO 9001 Certification 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.

Is it necessary for an organization to have ISO 13485 if they want to apply for the CE mark of any medical device?

ISO 13485 is the QMS standard accepted as the basis for CE marking medical devices. CE Marking is the product Certification and ISO 13485 is the basic requirement for an organization.

What does obtaining ISO 13485 Certificate mean?

A) Obtaining and maintaining ISO Certification is but a section of the whole business plan.

B) Focuses on the practices the business employs to maintain quality within the company.

C) Set the structures within which the operations function. 

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