Our medical device testing experts assess the strength, resistance, durability and ageing of various types of joint endoprosthesis, osteosynthesis products, trauma products, surgical instruments and tissue adhesives. We also provide manufacturing and development services to help quickly get your medical devices on the market.
We hold the required accreditations to test the materials, components and complete devices to the major international test standards, and we also develop new test procedures for innovative products including where no relevant test standards could apply.
At Applus+ Laboratories, we pride ourselves on being able to provide a complete medical device testing service. Our objective is to offer our clients a full one-stop-shop for testing, developing, and ultimately marketing their medical device innovation and to ensure they receive the highest quality service while we do so.
Here’s a breakdown of our carefully crafted medical device testing journey, from simulation and strength assessments all the way to cleaning and packaging validation.
Simulation and strength assessments are crucial in the development of your medical device, ensuring that it is fully optimised even during its design stage.
With material efficiency and design innovative pushing the boundaries, our medical device testing experts at Applus+ Laboratories perform an extensive range of tests so that even the more innovative designs can break into the market as quickly as possible.
In our state-of-the-art testing facilities, we conduct rigorous medical device testing, including:
Our strength assessments also include evaluating the worst-case geometric variant of your medical device to reduce costs and testing times. This means we fully test your product’s endurance even at its most extreme.
Applus+ Laboratories also offers Finite Element Analysis (FEA) to assess your medical device’s dimensions, aiming to find the optimal mass and shape, offering our expert testing recommendations on how to improve your device. FEA includes:
In addition to design, Applus+ Laboratories also provides medical material and coating testing to assess their suitability for long-term endurance after implantation. Testing materials and coating involves analysing material samples as well as finished implants and surgical instruments ensure an increasingly reliable product for the patient.
At Applus+ Laboratories, we are accredited to carry out materials tests for metals, plastics and ceramics and on all coatings.
Applus+ Laboratories performs full lifecycle testing on implants as well as comprehensive biomaterials testing. These tests are critical for confirming the lifecycle of an implant by simulating how it can withstand wear and tear over long-term use. Applus+ Laboratories is fully accredited to perform all the necessary testing to get your implant to market as soon as possible.
Here’s an overview of the medical devices we test on:
Joint implants are loaded for up to ten million cycles in the anatomically correct position under physiologic conditions in our laboratories, and we perform tests that simulate the full lifecycle of an implant. Here’s a full list of the testing services we provide:
We also offer optional Artificial Aging of UHMWPE components according to ASTM F2003 for a duration of 2 weeks.
After medical devices have undergone the vital strength and simulation Applus+ Laboratories provides the necessary product and process qualification culminating in batch release tests to ensure compliance and quality before market release. These involve several tests for chemical characterisation, biocompatibility, cleaning, packaging, and then stability:
With material and chemical characteristics, the composition of the medical device’s materials is analysed and assessed to get an idea of what impact they may have on the human body. This involves breaking down the device to its material components, identifying whether there are any contaminants that could cause potentially harm.
Applus+ Laboratories has extensive 20-year experience in Biocompatibility testing, essential for ensuring that a medical device does not result in adverse reactions or cause the human body harm due to the materials used in the device. Biocompatibility requires physicochemical characterisation of extractables and leachables, followed by a toxicological analysis and, if necessary, additional in vivo and in vitro tests to determine the biological risk of the medical device.
In addition to biocompatibility testing, cleaning validation is also important to control the removal of residue or contaminating substances from a medical device to guarantee the effectiveness of its cleaning process.
Packaging validation assesses the effectiveness of medical device’s packaging, from ensuring it’s maintained sterile and sturdy enough to protect the product, as well as ensuring its safety during transport. Packaging validation is vital also for making sure that the medical device can be well-preserved during storage.
Lastly, stability validation tests the product for its storage longevity. The medical device is tested under various conditions according to temperature and humidity exposure to see how well the device retains its quality and sterility during its shelf life.
Applus+ Laboratories is also a contract manufacturing organisation (CMO) that provides development services for your medical devices. These services include helping you with medical device discovery and development in order to bring your product to market as quickly and smoothy as possible.
At Applus+ Laboratories, we provide CMO services for:
In addition, we also provide:
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