Medical Devices

The leaders in the Medical Devices sector are the companies that market a product that not only works, but continues to work significantly. Medical device developers have to comply with strict safety requirements, which are regularly subject to change. When an organisation doesn’t meet these requirements, the safety is at risk and costs can quickly add up.

Safely and efficiently

With Icologiq Elements, your organisation meets all of the international standards and guidelines at all times, allowing your organisation to work more efficiently worldwide and to avoid unnecessary costs. Icologiq Elements contains all the building blocks for a safe digital quality system in accordance with ISO 13485: 2015. Elements is also suitable for use within multiple locations. The system is quick to configure and implement and relieves employees of routine tasks, so that they can focus on their core tasks.

A clear story

The most important advantages of a well-functioning quality management system at a glance.

Document control: working with a medical device without the correct documentation, is basically waiting for an accident (or an audit) to happen. An automated document management system creates order in your documents, so that you can easily find them whenever you need them. In addition, when you make an adaptation to a document associated with a particular product, the system uses automated workflows to implement changes accurately and in accordance with regulations.

Collaboration made easy: a QMS keeps track of which employees are linked to a particular product – from the suppliers of raw materials to the people who manage quality in the office. When it comes to non-conformities, you can use workflow automation to immediately inform everyone involved of any problems that need to be resolved. This way, everyone can take immediate action without wasting valuable time.

Proactively identifying problems: as more and more medical devices are IoT compliant, a QMS can monitor the information generated from these devices and initiate proactive responses in case of non-conformities.

Vendor management: If a company requires her suppliers to meet certain criteria, the QMS can provide the platform for entering and updating information about the suppliers’ quality management.

Icologiq Elements

The central element to our digital quality system for Medical Device companies is Document Management: an electronic document management system, which can be used to manage all types of documents and files. The system supports compliance with MD regulations, meaning you automatically comply at all times with the various legal and regulatory requirements around the world. Electronic workflows reduce the amount of paperwork, support quality processes and lead to a more efficient working method. By putting the responsibility for working safely, in the hands of the lower management, you only automate the things that need to be done and not how they need to be done. This way, your employees are free to design their work according to their own insight – within the rules. This ensures you are compliant with the regulations at all times, without decreasing user-friendliness, effectiveness and job satisfaction.

The advantages

A multi-site applicable web based platform.
A complete, configurable QHSE application portfolio.
A set of tools for continuous improvement.
Compliance with 21 CFR Part 11.
The ability to easily manage the system from a central point in the organisation.
The possibility of easy local implementation.
An excellent performance.
The basis for Operational Excellence.

Case studies

Inspiring case studies about the unlimited possibilities of Icologiq Elements. How leading organisations in their sector apply this platform to digitise and standardise their global processes.

Medicc Sports

Medicc Sports is an international organisation that helps athletes reach better performance, a pleasant sports experience and more fun. This way, every athlete can pursue their personal goals in the sport and simultaneously push their boundaries. The development and production process of Medicc Sports falls into the category Medical Devices. Therefore, Medicc Sports International can use the Document Management and Product File module of Icologiq Elements. By using these modules, Medicc Sports International meets the requirements set for an organization that develops medical devices.

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