Quality Management Software for Medical Devices

MedQdoc FAQs

MDR and IVDR require more medtech organisations to implement a QMS and many are turning to an eQMS such as MedQdoc, which will help modernise and simplify your processes, providing the regulatory framework for your industry.

Explore our frequently asked questions to learn more about MedQdoc. Please contact us if you have any questions and our specialist team will be more than happy to help.

Screenshot of MedQdoc validated QMS software interface on desktop monitor

Understanding MedQdoc

What regulatory frameworks does MedQdoc comply with?

MedQdoc packages offer you the ability to comply with MDR 2017/745, IVDR 2017/746, ISO 13485:2016, ISO 14971:2019 and QSR 21 CFR part 820. MedQdoc is also easily adaptable to comply to ISO 27001, ISO 14001 and other ISO management system standards. Read our blog for key considerations when implementing ISO 13485

Who are typical MedQdoc customers?

MedQdoc is suitable for all organisations operating within the medical device industry. MedQdoc is ideal for companies of all sizes, from small start-ups just launching their first product, to global organisations with a vast medical device portfolio. Our users have all kinds of products, but the one thing they all have in common is their relationship with medical devices.

How long does it take to get ISO13485 certified utilising MedQdoc?

Every company and medical device is different, so the exact timeline to certification depends on where you are as an organisation. However, to give you an approximate guide, our customers have taken anything from 4 months to 18 months to achieve certification. Read the MedQdoc case study to discover how NORBIT achieved ISO13485 certification within 6 months from software installation >

How difficult is it to move from a paper-based QMS system to the MedQdoc eQMS?

Moving from a paper-based system to an eQMS is a common process, and one we are used to managing. We have processes in place to guide you through this journey and we are happy to share them with you. Many of our customers have found it surprisingly straightforward to make the shift and wish they’d done it years ago! Read our blog for the best tips and trips that are key when setting up or adapting your QMS >

How do I evaluate MedQdoc specifically for my organisation?

Please get in touch and we will be happy to arrange a consultative meeting. Together we can discuss your needs, your specific area of the medical device world, your business priorities, your timescales and more. We can use our extensive experience to help you identify and understand the opportunities and suitability quickly, and we can also arrange for you to have a demonstration to see how MedQdoc might suit your company. Request a MedQdoc consultative led demonstration here >

How much does MedQdoc cost?

MedQdoc pricing is based on the number of users you have. You can also select from a range of training packages to purchase, for additional support from our expert team. For a full price list, visit our Pricing page. MedQdoc pricing information >

MedQdoc features and functions

What QMS templates are included?

MedQdoc includes over 130 ready-to-use templates created by our medical device quality and regulatory compliance experts. They cover all the areas you will need to meet ISO 13485 or QSR requirements, including management responsibility, design and development, risk management and much more. QMS template list download >

Do you include templates for technical documentation?

Yes, your MedQdoc package includes comprehensive technical documentation for both IVDR and MDR to help you on your journey to regulatory compliance and make the process as straightforward as possible. You can download details for them below. IVDR technical document list download > MDR technical document list download >

Can you modify the process maps in MedQdoc?

Yes, MedQdoc is designed to make your life easy. It includes a simple drag and drop design feature for modifying or creating process maps, and a series of template icons you can utilise. Request a MedQdoc consultative led demonstration here >

Does MedQdoc come pre-validated?

Yes, MedQdoc is validated following the rules in ISO 13485 sec. 4.1.6. The MedQdoc validation packages include the following documents:

Validation strategy
Validation report
Validation plan
Risk analysis
System performance & traceability matrix
Test case protocols & reports
Configurations & settings
User requirement specification
Detail requirement specification

MedQdoc is adaptable and can be tailored specifically to your organisation’s needs, and we can work with you to ensure validation of any changes.

Does MedQdoc meet FDA CFR part 820 (QSR) requirements?

Absolutely. All templates have been equally focused on QSR and ISO 13485. MedQdoc also enables you to tag all documents that relate to both QSR and ISO 13485, ensuring no work is duplicated.

Is MedQdoc 21 CFR Part 11 compliant?

Yes. MedQdoc comes with a validation package and has, for example, a Part 11 compliant reviewal and approval process with secure password authentication. Read our blog to learn more about how an eQMS can help you with 21 CFR Part II compliance

Does MedQdoc have a separate module for CAPA, non-conforming products and complaint handling?

Yes. The case management function comes prepared with adapted workflows for CAPA, complaint handling, non-conforming products, change management, general nonconformities and supplier management. Learn more about MedQdoc’s functions >

Can I make MedQdoc compliant to other ISO Management System Standards?

Absolutely, and several customers do. MedQdoc is structured according to ISO 13485 but can be adapted to ISO management system standards such as ISO 9001, ISO 27001 and ISO 14001 with just a few tweaks and additions.

MedQdoc services and support

How do I get started with using MedQdoc?

We have structured training and project options for you to select from, based on the level of support you require. This will depend on a number of factors including your timescales, existing QMS systems and experience. Find out about our pricing and implementation plans here >

How do I install MedQdoc?

Once the AM System license agreement has been signed, your organisation’s MedQdoc cloud site will be prepared and installed for you. From signing the agreement, it typically takes just 1-2 weeks to get a site installed and ready for you to start using.

Do you offer training for MedQdoc?

Your initial subscription includes introductory training to get you started, and we offer additional dedicated training for users or system managers to help you make the most of the system. Learn more here >

Do you offer consultancy and full project management services?

Absolutely, we can offer consultancy and project management that meet your needs. MedQdoc partners with medical device quality and regulatory compliance consultants when additional project services are required, and these experts help our customers maximise what MedQdoc can deliver. For full project management please contact the MedQdoc team and we’ll be happy to help. You can find training and project launch information here >

MedQdoc licensing information

What is included in a MedQdoc subscription?

MedQdoc is a ready-to-use medical device eQMS with over 160 templates and technical documentation included. It is packed with features including record management, version control and audit trails, which not only make it easy to use but also save you time. MedQdoc also offers a simple search function and intelligently links documents and procedures with related process maps, documents and cases for easy navigation. There are no expensive add-on features – everything is included in your standard subscription. Learn more about MedQdoc’s features here >

Is MedQdoc available in my region?

MedQdoc is cloud based, so has the flexibility of being available to use anywhere in the world. While we are headquartered in the Nordics, we operate globally and have a number of international customers. Currently MedQdoc is available in English only.

Do you have any other questions about MedQdoc?

If you have any questions which we haven’t covered, or if you’d like more information about any aspect of MedQdoc and the implementation process, please get in touch and our team will be happy to help.

Medical Device eQMS

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Class I Medical Device Manufacturers Need an established QMS Under the New MDR