Whether it is the Food and Drug Administration (FDA), the European Union Medical Device Regulation (MDR), the National Health Surveillance Agency (ANVISA), or the Health Sciences Authority (HSA), all medical equipment and devices need to pass certain audits coming from governing authorities in the respective countries they are registered in. The nature of audits varies depending on country, governing authority, and classification of the medical equipment in question.
Passing audits is crucial for initial market entry and also to ensure ongoing product sales for distributors. Due to their impact on the running of a business, the desire for a good audit rating is high.
What constitutes compliance in the MedTech world?
One of the most discussed regulations by the FDA, which is critical and challenging to meet, is to guarantee traceability and tracking of medical devices such as implants:
The FDA says
“Manufacturers must adopt a method of tracking devices whose failure would be reasonably likely to have serious, adverse health consequences; or which is intended to be implanted in the human body for more than one year; or are life-sustaining or life-supporting devices used outside of a device user facility”, “Tracking information may be used to facilitate notifications and recalls ordered by FDA in the case of serious risks to health presented by the devices.” (source: FDA, author: FDA)
Such standards can be challenging for some MedTech organizations. Why? Even with the right compliance tools and processes, MedTech companies encounter challenges in meeting standards due to poorly integrated systems. Excel sheets and external software, lacking full integration with the ERP system, often generate inaccuracies. This lack of integration can produce unreliable data and processes, which can lead to failed audits.
What is the best practice for ensuring you can always track and trace your products?
Do it inside your ERP system!
From an IT perspective, we recommend following the golden rule: Less is more. Avoid overloading your organization’s infrastructure with standalone apps and software not integrated into your primary system– your ERP.
What if your ERP does not support the processes and features you need to maintain compliance? Is there a cost-effective way to reduce stress, costs, and risks while maintaining compliance?
Choose solutions that sits inside your ERP system, literally! Your organisation’s primary focus should be on software and apps that are custom built for your ERP system. A solution aligned and integrated with your ERP system, mymediset is the exclusive add-on solution for organizations running on SAP® ECC and SAP® S/4HANA, designed for the MedTech industry. Plus, it’s certified by SAP®.
Compliance is easy to maintain with mymediset’s unique track & trace technology, customisable to regulations of governing authorities. It records items assigned to consignment inventory, including complete product characteristics such as serial, batch, and lot numbers. Patient data is linked to product consumption in a hospital, enabling smooth product recalls. mymediset includes mobile apps for external users, such as hospital staff, and sales reps, in addition to backend solutions.
Curious to learn streamline your compliance process? Speak to a mymediset expert today!
