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DATA MODUL is certified in accordance with ISO 13485

Implementation means added value for medical customers

DATA MODUL (DMO) works continually on the expansion of its service portfolio and from now on offers medical technology customers substantial added value in the development and production of professional control units for medical applications, with its ISO 13485:2012 certification. In December 2015, the Munich specialist for visual solutions decided upon this step and already received the certification from the TÜV (Technical Control Board) only one year later. Dr. Florian Pesahl, Chairman of DATA MODUL AG: “The swift implementation of the certification requirements is also due to the new strategic DMO development program Shape 2020. With this step, we are further enhancing our profile as a specialty supplier for display and system solutions, including for the rapidly growing medical market. All our employees are involved and highly motivated.”

Up to now, DATA MODUL has already supplied medical technology customers, but system and system component deliveries had to meet certain requirements, such as e.g. additional monitoring standards and product tests by the customer.

With the ISO 13485:2012, the internationally recognized standard for quality management systems (QMS) for medical product manufacturers, and the related adjustments that have been carried out – especially of the value-adding processes – to the regulatory requirements of medical technology, DATA MODUL now fulfills all normative conditions for medical product systems right through the product life cycle.

Added value for the customer

In addition to clear rules in the value creation process, standards create standardized process steps and an internationally valid framework of understanding, for all process owners/partners/suppliers/companies, because a uniform language is being spoken. For the customer this means less time and money has to be spent on additional monitoring. Customers can rely on consistent and documented product quality and safety (e.g. fault prevention by systematic risk management) and also claim a right to them.
Customer requirements are identified and implemented by means of systematic process steps, especially through close communication with the customers. 

In particular, systematic furnishing of verification and documentation is incorporated in the development and production process for the whole product life cycle, as well as constant risk and safety considerations.

Investments were necessary

The standard’s stipulations were implemented in several steps through all departments and required various investments as well as time resources: From the process modeling and maintenance software to internal training courses, employee qualifications including as medical product advisors (Rights & Duties, Approval, Procedures), the installation of a qualification matrix for the assessment of employee abilities, to the establishing of special workplaces, including a decontamination area.

Michael Scheuenstuhl, Managing Director of DATA MODUL Weikersheim GmbH: “With this certification we are creating enormous added value for medical technology customers and we are making it possible for ourselves to substantially expand our expertise in the development and production of systems.”

The essential changes/replacements within the processes

  • Device Master Record (medical device record, documented from the idea to discontinuation)
  • Customers’ requirements of the medical technology are documented and verified through all processes
  • Risk management through the whole product life cycle
  • Defined and described processes via the complete value creation chain from sales, development, and production to service
  • Effects on the organization due to adaptation to the new processes: Responsibilities and team leadership were reorganized and the communication structures were adapted to the new processes
  • Implementation of a software life cycle process
  • Revision of the process of procurement/supplier management including the handling of critical components

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