Quality management systems for medical devices and in vitro diagnostics

The international standard ISO 13485 forms the basis for the certification of quality management systems in companies that manufacture or distribute medical devices - or that are involved in their manufacture as part of the supply chain.

In terms of content, it addresses the requirements that medical device manufacturers and suppliers must meet in developing, implementing and maintaining management systems for the medical device industry.

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Process reliability through documented procedures

Proof of compliance with legal requirements

Increased product safety for patients & users

Increased customer & employee satisfaction

Highlighting the competence of the company

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Quality management systems for medical devices and in vitro diagnostics (SCC)

A quality management system forms the backbone for the activities and tasks of a medical device manufacturer. It ensures that internal and external regulations to be complied with are reliably taken into account and adhered to.

Appropriate certification enables a manufacturer to build confidence in its processes and products and demonstrate its commitment to safety and quality.

Beschreibung Standard/Regelwerk
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What is ISO 13485?

ISO 13485 is a stand-alone standard for quality management systems for manufacturers of medical devices or in vitro diagnostics, derived from the internationally recognized and accepted EN ISO 9000 series of standards. ISO 13485 continues the process-oriented approach of ISO 9001 and supplements it with specific aspects that are of particular importance for manufacturers of medical devices or in vitro diagnostic medical devices.

Grundsätze
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What are the contents of ISO 13485?

ISO 13485 supports manufacturers in developing a quality management system that enables safe and effective processes. These processes are designed to ensure the consistent design, development, production, installation, delivery, monitoring, tracking and disposal of medical devices, covering their entire product life cycle.

This is to ensure that medical devices and in vitro diagnostic medical devices can be used safely for their intended purpose.

Gesetze
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What is the legal significance of ISO 13485?

Regulatory approval programs for medical devices or in vitro diagnostic medical devices are often based on requirements of ISO 13485. The general requirements of ISO 13485 are expanded and adapted to specific legal market requirements through concretizations and supplements.

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What is the difference between ISO 13485 and EN ISO 13485?

While ISO 13485 is the internationally recognized basic version of the standard, it has been harmonized into a European standard by the European standardization body for its consideration in European regulatory approval procedures.

By complying with a harmonized standard, a manufacturer can prove that its products or services comply with the technical requirements of the relevant EU legislation and, if necessary, also claim the so-called presumption of conformity.

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How does a certification according to (EN) ISO 13485 work?

In the first step, you discuss your company and the goals of an (EN) ISO 13485 certification with us. Based on these discussions, you will receive an individual quote tailored to the needs of your company or organization.

After acceptance of the offer and before the actual audit, a gap assessment or project planning meeting can be useful to prepare for the next steps. A gap assessment offers a good opportunity to identify strengths and improvement potentials of your quality management system in advance. A project planning meeting can be useful, especially for larger projects, to plan and coordinate schedules that combine auditors from several sites.

The assessment of your quality management system is carried out in stages using a system analysis (stage 1) based on your QMS documentation and a subsequent on-site system assessment (stage 2), in which an experienced assessor evaluates the effectiveness of your processes for compliance with applicable requirements. The results are presented to you at a final meeting, along with the next steps on the path to their certification. You will receive a detailed report summarizing the results once the next step certification decision has been made.

The results from your system assessment are evaluated by an independent panel of experts, who confirm or reject the assessor's certification recommendation. If there are any questions regarding the content, we will contact you.

If you can prove that all requirements have been met, you will then receive your (EN) ISO certificate.

In order to maintain your certification, we must carry out our surveillance activities at regular intervals in the form of an annual surveillance audit.

Should there be any changes to your quality management system within a certification cycle, we will adapt our surveillance activities accordingly and include them in the audit cycle.

A certification according to (EN) ISO 13485 has a maximum duration of three years, but you can seamlessly combine it with a subsequent audit cycle by applying for recertification.

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What does certification according to (EN) ISO 13485 cost?

The costs of certification according to ISO 13485 depend primarily on the size of your company but also on the complexity of your processes and your organizational structure. We will be happy to provide you with an individual quote.

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Why should you have your company certified to (EN) ISO 13485 with DQS?

  • Recognized expertise in medical devices for more than 20 years
  • Active participation in standards and technical committees
  • Broad product portfolio of various normative and legal certification programs from one source
  • Worldwide network with over 200 experienced assessors and experts

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