Medical Device Testing: Powerful Solutions for Unique Challenges
Medical engineering requires incredibly exacting quality assurance standards—ultimately, patient safety depends on it. Even in the high-precision world of material and components testing, the stringent regulatory and safety requirements of medical testing stand apart.
In this blog, we provide a concise overview of medical device testing, why it’s one of the most challenging industries for testing technology, and how ZwickRoell has helped our customers meet this challenge head-on. Along the way, you’ll find links to our in-depth resources on key medical device testing equipment and capabilities.
Why is medical device testing so challenging?
The heightened safety and quality assurance requirements for medical devices translate directly into intense demands on testing technology, including:
- Hardware: extensive legal requirements for process validation involving technical review of individual plants and pieces of equipment. In addition to validation of testing equipment themselves, testing activities must comply with clean room requirements and include systems for climate and temperature testing.
- Software: regulations (such as FDA 21 CFR part 11in the United States) require software to support increasingly robust traceability for all completed actions.
- Documentation: GAMP5 and other current guidelines require extensive documentation every step of the way to ensure that processes meet current best practices.
For medical device manufacturers, these requirements add up to a genuine operational challenge. ZwickRoell’s medical device testing solutions are carefully designed to provide top-quality testing while directly helping testing operators fulfill all the requirements above (and more).
How ZwickRoell Medical Device Testing Solutions Can Help
ZwickRoell offers a variety of medical device testing solutions covering both material and component tests. Purpose-built for medical device testing applications, our industry offerings provide key features geared carefully to unique challenges in this space.
Our team offers support for customers across all stages of process validation for new testing systems, including DQ (Design Qualification), IQ (Installation Qualification), and OQ (Operational Qualification). Our expert technicians can take on the meticulous commissioning and calibration work needed to help ensure a successful qualification process.
Our testXpert software offers Expanded Traceability Functionality, which enables logging of all actions before, during, and after a test to ensure that results are exhaustively documented, tamper-proof, and FDA 21 CFR Part 11 compliant.
Example Medical Device Testing Use Cases for ZwickRoell Equipment
ZwickRoell’s extensive portfolio of medical device testing equipment includes modular machines, specimen grips, and software. This flexibility allows our solutions to be adapted to a wide range of operating requirements.
The systems below illustrate the breadth of ZwickRoell solutions for medical device testing. Across all these solutions, ZwickRoell testing machines can be readily tailored to the requirements of their operating environment—whether that’s a self-contained, tray-loaded unit for small testing lab, or a fully automated system employed in a large manufacturing facility.
- Therapy Systems: drug delivery systems and injection devices for outpatient, hospital, and private use.
- Autoinjectors are one prominent example, requiring incredibly complex testing of factors like removal force for the safety cap, activation force of the autoinjector, timing, administered drug volume, safety function of the needle guard, and more.
- Catheters and Stents: stents are an increasingly common cardiovascular treatment, while catheters open new options for minimally invasive surgery. These devices are inserted inside patients’ blood vessels and must pass a variety of tests including horizontal testing for catheter systems, lubricity track force tests, and load-testing for stents.
- Biomechanics and Orthopedics: testing for products like orthopedic implants, osteosynthetic implants, and prostheses.
- Latex, Rubber, and Silicone Products: these materials are used in a huge diversity of medical applications. Zwick has successfully provided testing solutions for products ranging from contact lenses, to condoms, to rubber gloves.
- Surgical Instruments: testing systems for fundamental surgical tools like scissors, scalpels, forceps, drills, surgical needles, and endoscopes.
- Dental Materials and Devices: from chewing simulators to dental implants, dental solutions require extensive testing just like regular medical devices.
- Medical Textile Products: textiles play several crucial roles for patients, in the form of bandages, swabs, gauze, compresses, sutures, and more. Protective textiles for physicians and nurses also fall under this category.
- Face Masks: testing for a variety of masks including surgical, basic mouth/nose protection designs, and advanced filtration solutions for small particles to class FFP1, FFP2 or FFP3.
- Medical Packaging: packaging plays an essential role insuring that those sensitive medical devices do not become damaged in shipping/handling or degrade during long storage periods. Common testing applications in this area include peel and blister packaging testing, Residual Seal Force (RSF) testing for vial lids, and screw-cap turning torque tests.
Learn About Medical Device Testing with ZwickRoell
We have completed qualification on over 1000 ZwickRoell testing machines globally. With over 40 years supplying testing systems for medical applications, ZwickRoell offers both the technical acumen and implementation experience needed to ensure that testing equipment delivers the most value possible.
Our medical device testing team takes pride in matching the optimal testing solution to each client’s unique business requirements, and we look forward to discussing your testing challenges. You can reach out using the button below.