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 the governing authorities in the respective country they are registered in. The nature of these audits varies depending on the country, governing authority, and the classification of the medical equipment in question.
Passing these audits is crucial not only for the initial go-to-market strategy, but also to ensure that a product that’s already on the market can remain there and the distributor can continue to sell it.. As these audits happen on a regular basis, you’d want as much help as possible to make them go smoothly, right?
So, is there a cost-effective way to reduce stress, costs, and risks while maintaining compliance?
Let’s look at one of the most discussed regulations coming from the FDA. A very sensitive and challenging regulation 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)
What sounds pretty straight forward can be challenging for some MedTech organizations. Why? Even if MedTech organizations have the correct tools and processes in place that comply with this regulation, if they are not well integrated with each other, they won’t make the life of regulatory affairs and other parties involved any easier. Instead, it leads to processes and data that are not as reliable as they need to be in order to pass an audit. This can happen when organizations are documenting essential data for tracking their products either manually, via excel sheets, or via an external software, app, or even with pen and paper. These tools are usually not 100% integrated with the organization’s ERP system. What happens then? Well, simply put, the data coming from those unintegrated processes should not be trusted, especially for an audit!
So, what’s 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. Don’t overload your organization’s infrastructure with apps and software that are standalone and not well connected with your number 1 system– your ERP.
What if your ERP does not support the processes and features you need to maintain compliance?
Go for a solution that sits inside your ERP system, literally! There are software and apps that are exclusively built as add-ons to your ERP system. These should be your primarily focused solutions as they are truly integrated with your main system. Plus, they are usually certified by the ERP solution itself, making sure it does what it says.
For organizations running on SAP® ECC and SAP® S/4HANA; mymediset is the exclusive add-on solution designed for the MedTech industry. Plus, it’s certified by SAP®.
mymediset’s unique track & trace technology makes it easy for you to maintain compliance with the regulations of any governing authority. It documents which items are at which consignment inventory including the full product characteristics such as their serial, batch, and lot numbers. When recording the consumption of a certain product inside a hospital, any patient data can be linked to that consumption, and any product recalls can be performed smoothly. It also conveniently comes with a backend solution, plus a mobile app for your sales reps or external parties such as hospital staff.
Curious to learn more and make compliance as effortless as it should be? Speak to a mymediset expert today!