It is hard to over-estimate the importance of quality and reliability in the area of medical devices since the lives and well-being of individuals are at stake and the industry is so tightly regulated. It is, therefore, a well-established area of standards and of scrutiny. Manufacturers and suppliers need to be vigilant, not least because any harm from unforeseen circumstances can lead to litigation against , suppliers, clinicians, and manufacturers.
The global medical devices industry is extensive and includes the simplest of mass-produced components to highly specialised one-off items and new materials development. With ever-increasing demand to drive down mass production costs and frequent introduction of new safety-oriented devices, it is essential that medical device manufacturers ensure quality throughout the design and manufacturing process.
Mecmesin, a PPT Group brand, specialising in the design and manufacture of force, materials and torque testing equipment has a range of test solutions for medical device quality control, designed to tackle a diverse range of test applications on medical devices and medical packaging including:
- Syringe glide effort
- Syringe pump calibration force
- Inhaler disassembly resistance
- Tubing pull-out resistance
- Needle strength, bend resistance
- Needle lancet retention
- Openability – peel and tear – of sterile packaging
- Puncture resistance of sharps containers
- Penetration of elastomeric closures
- Actuation force of pump and spray dispensers
- Torque assessment of Luer connectors
Mecmesin offer a wide range of products, from simple hand-held instruments through to fully comprehensive computer-controlled test systems to suit many test applications and budgets. The brand also supplies a wide range of accessories and gripping fixtures and in addition Mecmesin engineers can also design and manufacture bespoke solutions to meet your own unique criteria.
Gaining an in-house capability for quality assurance, rather than outsourcing, is a major cost and time reduction benefit for many of Mecmesin customers. Medical devices are often assemblies comprised of a number of individual components. Should a seal be out of alignment, the device may not function correctly and maintain its performance. Mecmesin testers can display an instant, pass/fail indication against defined criteria, immediately flagging a potential problem with a source of supply.
For example, the MultiTest 2.5-dV force tester provides outstanding value for compression and tensile testing up to 2.5 kN. Its simple controls, backed by sophisticated electronics, make it the ideal choice for routine testing when combined with a digital force gauge.
Sophisticated control electronics lie behind its unassuming and stylish control panel, comprising just four multifunctional operating buttons, a clear, bright colour display, and Mecmesin’s unique precision control wheel. The versatile wheel itself enables ultra-fine crosshead control, and rapid crosshead repositioning, whilst doubling up for changing machine settings of speed, set positions, and test type and parameters. The wheel is surrounded by coloured LED lights that indicate the test stand status at all times.
VectorPro Lite data acquisition software can collect the values of load, displacement, and time from the digital force gauge. It is ideal for applications where the true physical characteristics of the specimen cannot be detected by peak-load only and require a graphical presentation to highlight specific events during the test.
Mecmesin also supplies a range of bench top OmniTest Universal Testing Machines, which are driven by Mecmesin’s powerful and intuitive VectorPro™ testing software. VectorProTM software was developed in collaboration with Mecmesin’s customers within the medical industry. It enables compliance with FDA 21 CFR Part 11 and is packed with features and functionality to ensure data integrity. VectorPro utilises separate user accounts for individuals, enabling personalised workspaces, in the language of choice. This provides security for the organisation and simplicity for the user.
Core functionality of VectorPro software includes:
- SQL database – stores data for a secure audit trail of information
- Active Directory – ensures management controls around logins, User ID & password-complexity rules comply with your organisation’s established procedures.
- Electronic signatures – create, amend and approve test methods plus sign-off results generated from test calculations.
- Test reports – use customisable templates to generate reports exactly as you and your customers wish to see them.
VectorPro helps a manufacturer to track who did what, when they did it, and why, in case a faulty batch of medical devices or pharmaceuticals is accidentally sent to market.
Fully programmable force and torque testers take the variability out of quality testing medical devices and components. Using a library of international standard and custom test methods, they perform a wide range of tests, from the production line to the specialist design laboratory. Medical device and materials innovation demands detailed analysis of the mechanical performance of components since their application is so critical and highly regulated for safety.
Please stop by Mecmesin’s stand No. 30 at the Medical Technology Ireland exhibition and engage with our knowledgeable technical sales engineers. They’ll be delighted to address any questions you may have, helping you find the perfect test solution tailored to your specific needs.
Date: 20-21 September 2023
Location: Galway Racecourse, Ireland
Mecmesin’s stand: 30