ISO 13485 – Medical Industry

ISO 13485 QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES

With the help of Paragon Audit, maintaining QMS, certification and moreover continuous process improvement becomes easier than ever before.

The quality of medical devices, probably more than many other products, has a direct impact on the effectiveness and function of the product and the safety of patients. In addition, quality can influence users and possibly others. As a consequence, many national regulations require medical device manufacturers and providers to demonstrate that they have a quality management system in place. Whether you are in the process of preparing for certification or are already certified, with Paragon Audit you can reduce the effort by up to 60%. In addition to saving time and money, this also helps your employees to deal with the important issues.

Advantages of Paragon Audit in connection with ISO 13485

  • Business processes as a basis for auditing
  • Translation of strengths and weaknesses integrated
  • Relieve staff and increase productivity
  • Risk assessment of business processes at the touch of a finger
  • Requirements of ISO 13485 integrated
  • Action module for auditors and auditees – an end to email and Excel
  • Tablet, PC, notebook – you choose the system with us

WHY CERTIFICATION ACCORDING TO ISO 13485 IS HELPFUL


Medical devices that are manufactured or offered by companies that do not have a certified quality management system generally have a more difficult time being approved in important markets.

With the revision and introduction of the MDR (Medical Device Regulation), certification becomes even more important. Depending on the risk classification of a product, ISO 13485 is unavoidable.

The mandatory implementation of the MDR, for new products and those with an outdated approval, has been in place since 26.05.2021.

WHAT IS ISO 13485?

DIN EN ISO 13485 specifies requirements for a quality management system when an organisation is required to demonstrate its ability to provide medical devices and related services that continuously meet customer requirements and applicable regulatory requirements.

Such organisations may be involved in one or more stages of the life cycle of a medical device, including development, production, storage and distribution, installation or maintenance of a medical device and development or provision of related activities.

The standard may also be applied by suppliers or external parties providing products, including quality management system related services, to such organisations. It further describes the regulatory requirements of the European Union (EU), Canada and other major markets worldwide.


ISO 13485 is very closely related to ISO 9001 in scope and purpose. However, beyond ISO 9001, it contains additional, specific requirements for medical devices.

BUSINESS PROCESSES AS A BASIS

The company’s own process landscape always forms the basis for auditing. This is where Paragon differs fundamentally from so-called checklist apps. In Paragon Audit, you use the full database of your processes, including process owners.

The process categories, management processes, operational processes and supporting processes into which you have divided the processes are also used. Through this linkage, you ensure that the correct linkage between ISO requirement and associated process is audited.

In just a few minutes and very easily, you can complete these links once in the app.

COMPARABILITY THROUGH STRUCTURE

Every audit within Paragon Audit follows the same logical structure.

This guarantees a very high level of comparability of audits within your auditor team, across locations and also with external auditors.

Benefit from more than 20 years of experience in conducting management system audits.

You do not have to familiarise yourself with the auditing of different management systems again and you audit in an established logical sequence.

ISO 13485 AND MDSAP IN COMBINATION

ISO 13485 is a common requirement for establishing medical devices on the European market. But what if you also want to supply the target markets Brazil, Canada, USA, Japan and Australia?

With us, you simply audit the additional requirements of the MDSAP as well. Our smart MDSAP solution combines ISO 13485 with the regulatory requirements of MDSAP.

Advantages:

  • Bridge between ISO 13485 and MDSAP
  • Country-specific regulations integrated
  • Grading rules integrated
  • Automatic report according to requirements of e.g. FDA

Learn more about MDSAP audits with Paragon.



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