EDITOR ’ S CHOICE THE BENEFITS OF METROLOGY
SEMPRE GROUP
Taking better care of medical manufacturers
Ireland is one of the largest exporters of medical products in Europe , with annual exports of 12.6 billion euros . Medical device manufacturers in Ireland are constantly looking for new ways to enhance competitiveness , improve productivity and generate new growth in the area — could metrology make a real difference ? Here Jason McGlynn , commercial manager for Ireland at industrial metrology specialist , The Sempre Group explores three factors to consider when searching for a metrology supplier and equipment for medical applications .
The 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 . For metrology specifically , ISO 13485 lays out how to maintain an effective quality management system specific to the medical device industry , covering every stage of product lifecycle from design to disposal .
ACCURACY 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 to validate a variety of parameters , from dimensions to surface characterisation . This equipment can effectively validate the accuracy of devices , so long as it is calibrated correctly . So , when looking for a metrology supplier , medical manufacturers should check that a supplier ’ s equipment and services meet relevant standards .
ISO 17025 accreditation and certification from the United Kingdom Accreditation Service ( UKAS ) demonstrates competence and performance capabilities of organisations that provide certification , testing , inspection and calibration services . The Sempre Group is also one of the very few companies that is able to offer UKAS calibration for Optical or Vision CMMs , such as Micro-Vu systems , ensuring their reliability .
TRACEABILITY When applying to regulatory bodies for approval , medical device manufacturers need evidence to prove that the device safely and effectively meets its intended use . Proving compliance requires manufacturers to document every stage of the process – so improving traceability should be a priority .
Investing in automated , real-time data collection software , such as the Prolink SPC Data Collection Software , will help manufacturers spot any changes that occur during production and identify where they happen and why . It extracts result data from 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 successful it will be . Finding a supplier early in the process means that the metrology company can provide everything manufacturers need to improve quality at every stage of the product ’ s lifecycle , ensuring ISO 13485 compliance .
Smaller businesses can also benefit from involving metrology specialists early on so that they can build a solution that grows at the same rate as the project . The supplier can build bespoke systems to meet the needs of the application and upscale the solution as the medical manufacturer scales up production , ensuring that the solution will always meet production requirements .
UK and Irish medical device manufacturers know that metrology is needed to ensure a device operates to design intent and safety requirements . By considering metrology as a higher priority and investing in a fully integrated approach to quality , medical manufacturers can gain the competitive edge required in such a large industry .
Do you want The Sempre Group to be your one stop shop for metrology ? To find out more about the equipment , software and services that The Sempre Group offers to support you throughout the entire product lifecycle , visit www . thesempregroup . com or call + 44 ( 0 ) 1452 632 712 .
For further information , please visit www . thesempregroup . com
26 PECM Issue 48