As regulatory compliance experts in the medical device industry, we truly believe in the importance of having an efficient QMS. Having read the MedQdoc blog post on “Five Ways MedQDoc Adds Value for Medical Device Distributors”, we wanted to comment on the topic from a compliance consultant’s point of view.
Based on our experience in the medical device industry, we understand that many companies find meeting compliance requirements challenging, frustrating and time-consuming. Sometimes a bigger organisational change may be needed to drive compliance, but other times, implementing a robust QMS is the key to removing some of these apparent barriers to market.
Read on to find out our thoughts on the MedQdoc blog post from a compliance consultant’s point of view, and how an effective eQMS can improve your business operations.
The Risks of an Ineffective or Absent QMS
One of the first assessments we make when partnering with a new client is whether their QMS is effective and robust. As highlighted in the MedQdoc blog post, an ineffective or absent QMS can significantly increase a company’s workload and lead to potential operating issues further down the line.
Having visible, traceable and auditable documents is a key aspect of many regulations that are administered in the medical device industry. These documents are important for demonstrating regulatory compliance and not being able to establish this could impact a company’s ability to continue operating. These documents are also critical to other activities such as managing product recalls, handling customer complaints and overseeing supplier relationships.
Some companies that find themselves with insufficient or non-existent documentation might choose to retrofit their records. However, choosing this approach to ensure compliance can be time-consuming and can increase your workload. It can also be risky if you are unable to recall your activities accurately and fully. An effective QMS mitigates many of these issues by managing your processes in a structured and compliance-oriented way.
Compliance aside, a weak or absent QMS could mean lost opportunities for improvement. With our client partners, we advocate utilising a robust QMS as a tool for identifying and managing continuous improvement opportunities and as a way to add value to their business.
In What Ways Can an eQMS Add Value
to Medical Device Companies?
As regulatory compliance experts, we strongly recommend our partner clients use an effective QMS to manage their quality and compliance work. And as quality management system specialists, we would suggest using an eQMS, rather than a paper-based or DIY-style QMS to ensure all quality and compliance requirements are met fully.
We are experts in working with various types and brands of eQMSs and we are more than happy to work to our clients’ preferences. However, our experience tells us that not all eQMSs are made equal. We find that using an eQMS that is tailor-made to the medical device industry, like MedQdoc, gives you the best value and ensures a smoother journey to compliance. Here are some of the advantages of using an effective eQMS for medical device companies:
Understand compliance requirements easily using streamlined processes
MedQdoc is a bespoke eQMS that is tailored to the medical device industry. It cuts
through vague and confusing legal jargon by streamlining the regulatory and quality
compliance workflow to make sure the requirements are easier to understand by users of
the software. Not only does this help a company improve their awareness of their
regulatory responsibility, but they also have a better appreciation of how their activities
affect compliance requirements.
Give your suppliers and manufacturers confidence
An eQMS that is focused on the medical device industry, like MedQdoc, gives your external
stakeholders, like customers, investors and others, confidence that you are compliant with
regulatory and quality requirements. It also shows that you can guarantee that you have
control over the traceability of the devices you place on the market.
Save time with pre-validated templates
The MedQdoc blog post pointed out that the eQMS has over 130 pre-validated,
ready-to-use templates and tools. This comprehensive template library allows
companies to create compliance-ready and business-specific documents in a fraction of
the time and without starting from scratch. From our consultancy work, we know that this
is a valuable and much-needed time-saver.
Improve efficiency with streamlined workflows
As the eQMS is centred on helping companies achieve compliance and quality goals quickly
and effectively, the software is designed to be straightforward and intuitive to use. When
used effectively in an organisation, this streamlined process ultimately helps businesses
save time by shortening the implementation timeline and increasing business efficiency.
Facilitate orderly audits with easy-to-locate documents
Finally, a robust eQMS makes audits less overwhelming. By using your eQMS as a guide, your
systems and processes can be set up in line with compliance and quality expectations.
This means that your documents are visible, searchable and traceable so that when audit
time comes around you can quickly and easily locate the documents you need.
Final Thoughts
Many companies may see meeting compliance standards as a barrier to getting their products out to market, but that doesn’t have to be the case. We hope that this article has helped demonstrate why a robust eQMS is an important tool for improving documentation processes and shortening a business’s journey to regulatory compliance.
As regulatory compliance experts and quality management system specialists, we can help recommend systems that pair best with your company’s processes and accelerate your speed to market access. If you need any help with implementing a robust and compliant QMS, please don’t hesitate to contact us here at MedQtech.
MedQtech supports the medical
device industry to deliver effectively
