For Medical Device Manufacturers

Get MDR compliant with digital Quality Management Solutions

Are there too many documents in your QM manual that are filed by too many employees in too many different places? Is working with your QM system becoming more and more sluggish and cost-intensive? With our digital solutions based on the Ninox digitization platform, you can achieve enormous increases in efficiency.

Efficiently Implement Legal MDR Requirements for your Quality Management System

„It all takes far too long here!“ We hear something like this again and again from auditors when they tell us about their experiences with MDR QMS audits.

Many medical device manufacturers, especially the smaller ones, apparently often have problems making the documents requested as part of the audit available in a reasonable time.

As annoying as waiting for document inspection may be for an auditor, the real problem lies elsewhere. Because the following points in particular are criticized (in increasing relevance):

This not only casts a bad light on the audited company – in individual cases this can even lead to the effectiveness of the quality management system being fundamentally questioned.

As part of the EU MDR Medical Device Regulation, the establishment of a quality management system according to ISO 13485 becomes a legal requirement for manufacturers.

We all love flexible office applications. But there are also other suitable tools for organizing complex issues.

What's the problem?

In many companies, indirect business processes (e.g. quality records) are managed with the help of flexible office applications, e.g. with classic Excel spreadsheets.

The chaos often begins with the documents being stored in too many different file folders, teams, Sharepoint sites or document management systems.

And so many employees are almost only busy finding the right valid „referencing“ documents and then adapting „their“ documents to the latest version.

In the end, there is often uncertainty. Are our procedures and quality records really consistent with each other? Because no one has a full overview of what is where and how everything is actually connected.

A digital quality management system according to ISO 13485 could be the right solution for your company. Avoid inconsistencies, data breaks and multiple entries. Work with self-auditing forms instead of complicated body text. Implement changes at the push of a button. Be ready for the next audit at any time.

Your benefits​

Always ready for next MDR audit

Meet the MDR requirements for your QMS. Have your medical device files and quality records at hand at all times at the push of a button.

More efficient quality processes

Avoid data breaks, incorrect entries and GDP problems with our automated change management and self-auditing forms and workflows

Developed by experienced SMEs

Our end-to-end solutions are developed by quality professionals with years of experience at leading medical device manufacturers - with a focus on simple and safe usability.

Perfectly tailored to your needs

No matter it you prefer our best-practice forms and workflows or solutions that are flexibly tailored to the needs of your company - they can be seamlessly integrated with many IT platforms

High value for money

Thanks to a lean cost structure, we are cheaper than you might think - both when creating our customized solutions and in the long run

Modern cloud-based architecture

Our solutions are based on the established low-code digitization platform Ninox. This gives your QMS unbeatable performance, high data security and a modern web interface.

Digital Quality Management System According to ISO 13485

Have you been considering introducing an electronic quality management system according to ISO 13485 for some time in order to be compliant with the regulatory requirements of the MDR Medical Devices Ordinance?

But still not sure which modules to start with?

Your IT system landscape is complex and you fear that you will overwhelm your employees with another system?

Would you like to start with a smaller pilot project to determine the requirements for a holistic solution and a long-term roadmap?

No problem. We like to listen to you and your individual needs very carefully.

We always develop our solutions individually, for example based on the Ninox low-code platform. In this way, we ensure that our customers receive a modern, high-performance system and still remain significantly more flexible than with the large off-the-shelf industry solutions.

Document, approve and train your QM manual, including your quality policy, quality goals and procedural instructions, in an audit-proof and electronically searchable manner in one central location.

Assign your employees training for procedural instructions based on a role concept

As soon as relevant changes have been made to documents, follow-up training is automatically generated

Define periodic training for critical procedures

Document the digital training certificates of your employees in a legally secure manner

Control the access and change rights of quality-critical forms based on the role concept and training status

Manage the relevant properties and quality management workflows for your most important resources: your employees, your production equipment, clean rooms as well as measurement and calibration points.

Assess and manage your product risk, application risk and production risk.

Connect these risk analyzes to other modules, for example Complaints Management, Non-Conformance Management and CAPA Management.

Document the structure of your products using revision-controlled parts lists.

Define product requirements or assign specifications, drawings to individual product components.

Define manufacturing processes for each product component and assign appropriate process requirements.

No Data Breaks: Reference the defined products, product components and the corresponding requirements in your other quality records, e.g. pFMEA, batch records, complaints management, non-conformances

Manage your product design changes in electronic Design History Files (eDHF).

Manage your process changes in electronic process factbooks.

Easily create your validation plans with the click of a button.

Your equipment requirements are automatically loaded into the IQ plan. And your product and process requirements are automatically loaded into the OQ or PQ plan.

You can also create your qualification reports at the touch of a button.

Document your raw material specifications, supplier related qualifications, audits, corrective and preventive actions.

Document the production of your medical devices.

All quality-critical product and process requirements are automatically stored as tests for each order. Your employees can confirm the fulfillment of these requirements at the push of a button and also ensure quantity tracking and traceability.

Potential to develop a seamless  connection to your ERP system.

Document quality deviations in your production processes or your quality management system as well as best-practice workflows for risk assessment, application of corrective measures

Systematically improve your quality management system and your product development, production and sales processes

Document and evaluate customer complaints.
Derive suitable measures.
If necessary, automatically update your risk documentation.
Communicate reportable customer concerns, trends and safety related corrective actions in the field to the relevant Notified Bodies and Regulatory Authorities

Plan and document the implementation of internal and external audits

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