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.
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!
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.