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Five ways MedQdoc Adds Value for Medical Device Distributors

Pontus Axblom
By Pontus Axblom

Quality and Regulatory Advisor with over 15 years of experience from the Medical Device Industry.


Complying with MDR 2017/745 for distributors

MDR 2017/745 has increased the regulatory and quality compliance workload for medical device companies, including distributors, by introducing more and stricter requirements.

The specific MDR requirements for distributors are set out in MDR Article 14, General obligation of distributors.

With our medical device industry experience, we know that, we know that fulfilling these new demands can feel overwhelming and time-consuming, and like it doesn’t add value to your business. However, complying with the latest regulatory standards can give you a competitive advantage and improve the operation of your company.

Read on for a short overview of why an inefficient QMS can negatively impact your business, and the five ways MedQdoc adds value to you as a medical device distributor >

The risks to medical device distributors of not having a QMS

A weak, or lack of, QMS can have a number of negative consequences for your business:

Medical Device Distributors

Insufficient or non-existing records and traceability can severely increase your workload, for example when handling a recall.

Medical Device Distributors

Not maintaining an adequate process and traceability for handling customer complaints could harm the relationship with your suppliers if such information is ever required.

Medical Device Distributors

If audited by a competent authority and they assess that you lack regulatory compliance, it could impact your ability to continue operating.

Why is MedQdoc so valuable to medical device

As well as mitigating the risks associated with having an insufficient QMS, there are five key ways in which MedQdoc can add value to you as a medical device distributor.

Medical Device Distributors

You’ll have access to 130 ready-to-use tools and templates to enable you to fulfil the mandatory MDR requirements. Download the lists of templates available via MedQdoc for MDR, IVDR, ISO 13485 and QSR below.

Medical Device Distributors

MedQdoc streamlines your regulatory and quality compliance work, as well as increasing your team’s awareness of your regulatory responsibility and their understanding and application of compliance activity.

Medical Device Distributors

You’ll save time and money on your QMS, with a short, straightforward implementation timeline and increased business efficiency as a result.

Medical Device Distributors

MedQdoc enables you to give confidence to your suppliers and manufacturers that you meet regulatory and quality compliance, as well as providing a guarantee that you have control over the traceability of the devices you have placed on the market.

Medical Device Distributors

MedQdoc facilitates audits by external parties and enables you to quickly and easily locate your regulatory documentation whenever it is required.

Do you need an eQMS to help with your MDR

Created by our team of medical device and regulatory compliance experts, MedQdoc eQMS is designed to improve your documentation processes and shorten your journey to regulatory compliance. Please reach out to us to arrange a no-obligation consultative meeting to find out if MedQdoc could deliver value to your business.

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