Medical Devices & End-Packaging - Our Quality Insights
Discover exclusive insights into the testing and inspecting of medical devices and their end-packaging.
As a first-class medical device manufacturer, it is vital that your products perform to a high standard and meet various industry regulations.
Our exclusive guide offers insights into different types of testing we can offer to medical device manufacturers like you.
Learn how you can meet ISO 11607 (alongside other regulations) and discover the ways our team of experts can offer personalized solutions created especially for you.
Avoid product defects
It’s critical to ensure your name remains trustworthy throughout the medical industry. Product defects – no matter how small – can lead to hazardous consequences. Consequences that impact your finances, your reputation, and the future of your business.
For instance, in the United States, medical device manufacturers must ensure their products (including packaging and labelling) meet regulations set by Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). There’s often a multitude of criteria you’ll need to meet in order to achieve FDA approval, and other local regulatory bodies may well have their own deviations or criteria.
Ensuring that your products and end-packaging meet regulations and industry standards is critical. If a product meets the market and has a defect, such as packaging being unsterile, then this can lead to costly consequences - not only for your company and its reputation, but also waste for your customer by not having a viable product ready to use.
That’s why having the right test and inspection solutions in place is crucial – so you can be sure that your medical devices and associated packaging are upheld to the according standards.
Meeting Regulations - ISO 11607
Protecting medical devices and ensuring they remain sterile is absolutely vital
The international ISO 11607 standard offers a set of rules and guidance on how to make sure that a medical product and its packaging will arrive in a safe and sterile condition. From the manufacturer’s door through to the hands of the end user.
If you manufacture medical devices that play a key role in supporting surgery, or if you make products that are inserted into a patient to administer treatments, then there are a stringent set of packaging rules that must be adhered to. Rules that minimize the risk of your products becoming contaminated, and must be safe for patients and medical professionals.
It ensures medical devices are contained within a sterile barrier systems and are sterilized before reaching supply chains.
Therefore, ensuring your products are compliant to ISO 11607 – that they are safe, sterile and not contaminated - is of huge importance. ISO 11607 is recognized worldwide - from in the United States by the Food and Drug Administration (FDA) and across the European Union through the CE marking. It is seen and accepted in many other countries around the world.