SPONSORED FEATURE Taking better care of medical manufacturers
Ahead of the launch of its new facility in Dublin, Jason McGlynn, commercial manager for Ireland at The Sempre Group, shares his advice on what factors to consider when searching for a metrology supplier and equipment for medical applications
T
he goal of medical device manufacturing is to produce exactly what the patient needs. As such, manufacturers should
consider how they will validate the process to ensure this is the case. However, metrology is often an afterthought in the product’s lifecycle and is simply used to validate products and detect defects at the end of production. With regulatory requirements becoming increasingly stringent, there is added emphasis on proving safety and quality throughout every step of the product’s lifecycle. how to maintain an effective quality management covering every stage of product lifecycle from design to disposal.
ACCURACY AND TRACEABILITY Precision is key when manufacturing any medical device to ensure the best outcome for the patient. Take an insulin pen as an example – if any dimensions are slightly incorrect it could lead to false deployment, overdosing or underdosing – putting the user at risk. Manufacturers can
invest in nano and micro precision measurement equipment, such as the Jenoptik Waveline dimensions to surface characterisation. This equipment can effectively validate the accuracy of devices, so long as it is calibrated correctly.
from the United Kingdom Accreditation performance capabilities of organisations that one of the very few companies that is able to reliability. Proving compliance requires manufacturers to document every stage of the process – so improving traceability should be a priority. collection software, such as the Prolink manufacturers spot any changes that occur during production and identify where they
any device or machine and enables full analysis and reporting, providing total visibility and control across the entire process and reduces the risk of human error that comes with paper documentation. When choosing a software, medical manufacturers should also ensure it is 21 CFR Part 11 compliant, as it assures that any electronic documents generated are authentic.
THE FULL PACKAGE The earlier that manufacturers involve metrology specialists in a project, the more manufacturers can now receive expert, local support from our newly opened facility in equipment demonstrations in the showroom, receive training from the team or use The The one-stop-shop is less than a three-hour customers can easily pop in.
Sempre
www.thesempregroup.com
YOUR PARTNERS IN MEDTECH METROLOGY
The Sempre Group Ireland offers the full turnkey solution needed to improve quality at every stage of the product’s lifecycle from its new office in Dublin. We can solve your metrology challenges in:
Injection moulding Orthopaedics
Precision engineering Tool making
Additive manufacturing
www.TheSem Measu
Measurement Solutions accredited to ISO 17
Suppo urement Solutions a
www.TheSempreGroup.com
mpreGroup.com |
sales@thesempregroup.com
Supporting you from DQ torting you from DQ to PQ s
ISO 17025 and 21 CFR Pa to PQ
7025 +353 (0 21 CFR Part 11 sales@thesempregr
oup.com | +353 (0)860355649
0)860355649 art 11
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