Frequently asked questions about MedQdoc
Learn more about our eQMS for
the medtech industry
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.
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.
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.
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 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.
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 >
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.
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.
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.
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.
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.
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.
MedQdoc licensing information
What is included in a MedQdoc subscription?
MedQdoc is a ready-to-use medical device eQMS with over 130 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.
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.
What is AM System?
AM System is a cloud-based document management system, providing a digital platform for a huge range of industries. With over 44,000 users worldwide, AM System has been in the eQMS cloud service market for over 30 years.
What is the relationship between AM System and MedQdoc?
Based on AM System’s platform, MedQdoc offers a structured, content-based eQMS to companies in the medtech industry. MedQdoc uses the benefits of AM System’s flexible cloud service to provide a fast, ready-to-use eQMS solution to meet the unique demands of the medical device industry on a reliable platform.
What licenses do I need?
You will need an AM System license agreement that includes the MedQdoc package. All users in the system need to have their own user license, and the minimum number of licenses available is five. You can easily add extra users when required. The system administrator will assign each user a unique user identification and password.
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.Contact us
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