KIE systems

CE marked Medical Viewer software product

This collage is about the knowledge needed to get a CE marked medical device on the EU market. Emphasis is on the Quality Management System (QMS) and Summary Technical Documentation (STED). In this case the medical device is a software product, it is a diagnostic medical viewer for radiology, manufactured in The Netherlands for the EU market.

The search engine is using the following websites, rivm.nl and nen.nl are websites about regulations and standards in The Netherlands.

  • www.rivm.nl
  • www.nen.nl
  • ec.europa.eu/growth/sectors/medical-devices
  • www.iso.org
Entering "medical device" in the search box gives a lot of information about medical devices, regulations and standards. The purpose of the "Collage of Knowledge" is to present a subset of this information in an overview that can be reviewed on a regular basis e.g. change on regulations or standards or EU guidance. The subset of information is related to the process and QMS of the company (or organization in general) that manufactures the CE medical viewer.

Examples of a medical viewer

Process analysis

When a company manufactures a product intended for the EU market, the following have to be considered:

  1. the government has regulations related to medical devices
  2. because the product is meant for the EU market, EU regulations have to be followed
  3. to get a CE certificate, a Notified Body needs to be involved who will audit the company regarding it's Quality Management System and STED (Summary Technical Documentation)
  4. communication with (potential) customers is needed e.g. via a website, for post market surveillance, complaint handling and to make information regarding the product available (e.g. CE certificate, manuals, etc.)
The following website gives an overview of the steps to be taken to be able to trade the product on the EU market:

Knowledge identification

Based on the process analysis about getting a CE marked product on the EU market, knowledge about STED and Quality Management System get the focus. The following websites have important information:

  1. Medical Devices (It is important to check this website regularly for changes on regulations.)

  2. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

  3. List of guidance MEDDEVs

  4. What the Notified Bodies do: Conformity Assessment

  5. A common framework for the marketing of products (including technical documentation)

  6. ISO 13485 Medical Devices

    7. ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.

    It is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services.

Knowledge conversion

In the step Knowledge Identification, it is decided to put the focus on Summary TEchnical Documentation and Quality Management System for Medical Devices.

Explanation

Socialization: from tacit to tacit knowledge conversion
To get a good understanding of the Conformity Assessment by a Notified Body the R&D Manager will have several meetings with a consultant specialized in that field of expertise (e.g. another company that is also a Notified Body). The R&D Manager can discuss with the consultant the QMS and STED of the company regarding the medical device.

Externalization: from tacit to explicit knowledge conversion
Based on the information and understanding about the Conformity Assessment during the Socialization step, the R&D Manager can adapt the product development lifecycle process where needed. The product life cycle process will be presented and explained:

Combination: from explicit to explicit knowledge conversion
During the product lifecycle (which is a continuous cycle) the product will be developed, changes will be made and product versions will be released. The following knowledge will be used:

Internalization: explicit to tacit knowledge conversion
When the product has been developed, R&D will make their knowledge about the product available for Service & Support and Marketing & Sales via:

with the aim to help Service & Support with: with the aim to help Marketing & Sales with:

Prior to Product release
In this phase the following will be done:

An appointment will be made with a Notified Body for a Conformity Assessment. When the assessment is successful, the Notified Body will issue a CE certificate for the product and it will be delivered after some time.

Product release
In this phase the following will be put on a special part of the company website:

Customers will be informed how they can get access to the Complaint Handling website and the website for Post Market Surveillance.

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