Medical device packaging can be a complex process, especially when trying to achieve the highest standards in quality, safety, and regulatory compliance. When choosing the right medical device packaging machine providers, it’s crucial that you select companies that provide ISO-17025 accredited laboratory services and certification for medical device packaging machine calibrations and medical device pouch testing.
Keep reading to find out why you should always choose a laboratory that’s ISO-17025 certified for all your machine calibration and pouch testing.
What Does the ISO-17025 Accreditation Mean for Medical Device Packaging Machines?
Every ISO 13485 medical device company must work with vendor partners that share the same high level of quality if they are to avoid the weak link risk. When health and safety are at stake, finding a laboratory that can offer a full scope of service while meeting the highest industry standards is essential, especially if you’re looking to purchase medical device packaging machines.
Put simply, the ISO-17025 accreditation makes certain that these high levels of standards are in place. Granted by an authorized body, the ISO/IEC 17025 accreditation allows laboratories to demonstrate that they can operate with absolute competence and generate valid, watertight results. And certification of conformance from these labs can work as the headwater for medical device packaging validation for medical device manufacturers.
To achieve the ISO-17025 accreditation, laboratories must complete a dense checklist of quality procedures to meet compliance. The laboratory must also be carefully surveyed during an annual internal audit, this ensures each competency meets this advanced directive.
When looking to purchase a medical device packaging machine always be certain that the machines include a critical attribute calibration, and the medical device packaging machine is sent with certification baring the accredited body’s logo and scope of accreditation.
Advanced Machine Calibration Made Effective and Efficient
When purchasing heat sealers, band sealers, or other medical device packaging machinery, it’s important to ensure a comprehensive foundation for your installation qualification. The exacting quality system of the ISO-17025 accreditation makes achieving the best standards of machine calibration possible.
In Van der Stähl Scientific’s accredited laboratories, our sealers undergo an advanced calibration process in line with every necessary standard for compliance. Temperature calibrations are performed at multiple internal thermal zones, providing much better accuracy than a non-accredited service. Alongside this rigorous testing, verification of force against detailed specifications is also carried out, as well as multi-zone force calibration on the force transducers. The unit also verifies that the “Time function” on the system’s microprocessor is within tolerance, the adds to the aggregate repeatability of the medical pouch sealer.
Pouch Testing for Safety and Compliance
Medical device pouch testing couldn’t be more important for hospitals and other institutions to ensure patient safety through the delivery of a sterile medical device. To avoid compromising sterility, using heat sealers that have been calibrated and that match your specific requirements is crucial for good practice and sterile packaging validation.
At Van der Stähl Scientific, our accredited laboratory doesn’t just perform high-quality and advanced pouch testing. We have also developed our own patented technology, invented and developed to meet and surpass industry standards. We also provide pouch seal strength studies to help develop nominal machine settings ensuring consistency and compliance to medical device packaging standards such as the ISO 11607.
So, as you can see there is great value in working with an accredited ISO-17025 Laboratory. These high-level credentials only come to laboratories that have competent and well-trained staff as well as the state of industry equipment necessary to meet these strict quality standards.
If you’re looking to work with one of the nation’s best ISO-17025 award-winning accredited laboratory, contact Van der Stähl Scientific.
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