ISO 13485 Certification & Consultation

ISO 13485 Certification

Safety and quality are uncompromising when it comes to medical devices. A small safety issue could lead to a life or death situation. This is why the International Organization for Standardization (ISO) came up with the ISO 13495 standard that guarantees the safety of medical devices. It is an extension of the popular standard, ISO 9001, and hence also deals with the maintenance of an effective Quality Management System but specifically developed for the manufacture of medical devices.

Similar to ISO 9001, ISO 13485 is essentially about helping companies produce safe and high-quality products, consistently. However, ISO 13585 is specific to medical-based industries or organizations providing medical materials, services, or devices. Hence, it is focused on helping companies meet the specific demands and stipulations that come with manufacturing medical apparatuses and other healthcare-related components. The process of ISO 13485 certification is focused on ensuring safe and effective planning, development, production, storage, distribution, installation, service, and technical support of medical devices.

The ISO 13485:2016 is the latest revision of the standard that contains substantial updates relating to risk-based quality processes, supplier management, and strict adherence to regulative necessities. ISO 13485 is one of the product standards developed by ISO that define guidelines for the manufacturers to follow to ensure a practical role in the fight against the spread of the virus.

Why Choose Finecert for ISO 13485 Certification?

We, at Finecert, have a team of highly-efficient consultants who are passionate about helping clients obtain their desired certification be it any type of ISO Certification such as, ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 13485, ISO 50001, ISO 39001, ISO 21001, ISO 22301, ISO 20001, ISO 41001, or CE Mark, HACCP and GMP certifications. 

We have extensive knowledge and resources at hand that we believe will deliver the highest quality services to our clients. We utilize a cost-effective, time-effective, transparent approach and integrity is of the utmost virtue to us. Therefore, we have no hidden charges and every aspect of our services will be informed before project initiation.

Process of getting ISO 13485 Certification

The process of ISO Certification includes a few basic steps:

  • Gap Analysis: First we need to analyze your framework to set a guide on the necessary improvements
  • Scope and Design: Based on the information obtained from the first step, we will design the arrangements and solutions needed for an effective management system.
  • Implementation: This is the major step where all the required changes are put to effect.
  • Training: In this step, all the employees and staff will be trained.
  • Certification Audit: Auditors will visit your organization to audit the company and then provide you with ISO 13485 Certification.
  • Continual Improvement: Although we don’t mention this step, we provide continual services after the entire process of ISO 13485 Certification is completed. This ensures that the process of your management system flows continuously.

Benefits of ISO 13485 Certification

  • It will significantly improve the safety and efficacy of medical devices.
  • Increases the ability to identify and evaluate threats.
  • It will help show the customers and business partners how the company incorporates risk management principles into product realization.
  • Helps your business credibility and increases brand value.
  • It improves the involvement of employees and members of the organization.
  • It increases the potential profit and market share.
  • It helps to become eligible to apply for International and Government Tenders.
  • This signifies that your company considers providing good quality medical products or services.
  • Increases operational efficiency in a production environment and helps to improve performance. 
  • Get compliant with the legal, statutory, and regulatory requirements especially regarding grievance handling, regulatory notices, and post-market surveillance.
  • ISO certification helps the business with day-to-day activities performed by the organization.

Industries or organizations that can comply with ISO 13485 Certification

ISO 13485 is intended to be utilized by associations that deal with any medical-related materials, services, and products. The risk of contamination of medical devices is not only from improper conduct of the devices by people but also from raw materials, airborne particles, dirty machines, etc. Therefore, manufacturers of medical equipment and products must consider the prevention of risk of contamination of the device during the production process.

ISO 13485 applies to any type of organization in the medical field as it is designed to be used by organizations involved in any step in the process of the production and supply of medical devices such as the design, manufacture, installation, and services. It is the most significant and up-to-date standard for medical devices. Hence, any company that is keen on ensuring the safety of their medical devices can benefit from it. ISO 13485 applies to any organization in the medical field irrespective of its size. In fact, a medical-based company with a single employee can also obtain this certification.