ISO 13485 Certification

Content

All manufacturers are committed to meeting the highest international standards for the quality and safety of their medical devices. For this reason, ISO 13485 certification is required.

This standard was developed by the International Organization to assist manufacturing companies of medical devices. Russia created an equivalent standard on 01.06.2018 as a national standard of the Russian Federation – GOST ISO 13485-2017.

In order to obtain registration certificate and a license to service medical devices, as well as to pass inspections successfully, certification is now mandatory.

The main Essence of the International Certification System

The standard introduces fundamental quality parameters for the production of medical devices. These parameters regulate not only the reliability and safety of finished products but also the quality control process as a whole. It primarily concerns quality control at each production stage, and also ensures that the benefits of a medical device outweigh the potential risks.

Who Should Comply with ISO 13485 Certificate Standards?

First and foremost, this applies to manufacturers and designers of medical equipment. It is the responsibility of the company responsible for the maintenance of manufactured equipment during the warranty period could kindly ensure that separate certification is carried out.

It is applied by internal bodies that are responsible for the quality of medical devices. Supervisory bodies can use the standards to carry out audits.

Benefits of ISO 13485 Certification

Certification provides consumers and distributors with complete confidence that medical devices meet all reliability, efficiency and safety requirements confirming the high quality of their device.

  1. Medical devices comply with established Russian and international quality standards,
  2. Opportunity to enter the international market,
  3. The certificate allows increasing competitiveness,
  4. The user can be sure that he receives not only quality equipment, but also warranty service of the equipment for the entire operational period,
  5. Quality management controls the production process at all stages,
  6. Increased trust in the company from customers.
  7. Export of goods to other countries.

Documents Required for ISO 13485 Certification

To apply for ISO 13485 certification for a medical device or company, the applicant shall electronically submit the following documents or information to the certification body:

  1. Statement,
  2. Company data: details, documents: PSRN, ITN, RNCE, charter,
  3. Licenses and permits for production/provision of services indicating the types of activities,
  4. Information on compliance with SanPiN in production,
  5. Employee details: qualifications, their job responsibilities,
  6. Enterprise structure,
  7. Description of production.

Reasons for Rejection of Application

  1. The set parameters do not correspond to those stated.
  2. Failure to comply with recommendations for compliance with quality control regulations during the production process,
  3. Incorrect or incomplete filling in of documentation,
  4. Other technical errors.

Certification Deadlines

It is not possible to immediately establish the exact time for the development of documentation and conformity assessment; we can only give an approximate estimate. Timeframes are determined individually and depend on various factors. We are fully equipped to assist with any quality fulfilment requirements in the shortest possible time.

The certificate of compliance with the standards is valid for three years. There is no option to renew. At the end of three years, the entire certification procedure must be repeated.

Once the certificate has been issued, an additional inspection is carried out once a year to confirm that the company continues to meet the required criteria of the quality standard.

How to get a Quality Management System Certificate Quickly and Without Mistakes?

It is a legal requirement for manufacturers of medical devices to comply with the ISO 13485 certification conditions. Without the requisite permit, the device will not be eligible for sale in either the international or national markets. The conclusions of the supervisory board are taken into account by state supervisory authorities.

People often make mistakes when trying to get a certificate on their own.

To promptly obtain an international or national certificate, it is enough to contact our company’s specialists, who are familiar with the peculiarities of national and international law. We will prepare the necessary documents for you and get a ready certificate to you as quickly as possible.

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