With ever-tightening regulatory scrutiny and evolving pharmacopeial standards, medical device manufacturers face increasing pressure to ensure the safety and efficacy of products before they reach the market, as well as to trouble shoot during manufacturing. This involves a series of tests, evaluations, and regulatory reviews to ensure that devices perform as intended.
As the sector continues to expand with the development of novel medical devices, the need for fit-for-purpose analytical testing methods becomes more critical. These tailored approaches are essential to address the unique challenges of ensuring both the safety and functionality of increasingly complex devices.
RSSL’s extensive testing capabilities incorporates chemical, physical, and biological testing, providing a comprehensive solution for pharmaceutical and medical device companies. We collaborate closely with clients to overcome technical challenges and support the development of novel products. Whether the need is for regulatory compliance, investigations, or research and development (R&D), our team of technical specialists is available to design bespoke studies tailored to the specific requirements of each project.
To ensure patient safety, quality control, and ease of use, medical devices must be rigorously tested for functionality and integrity. RSSL has the technical expertise and instrument capability required to offer comprehensive testing services, including syringe performance (break force, plunger movement, barrel resistance) to ISO standards, nasal device actuation force, vial seal integrity, ostomy bag durability, and visual and dimensional inspections.
We also provide inhalation testing (Aerodynamic Particle Size Distribution, Delivered Dose Uniformity for Dry Powder and Metered Dose Inhalers), pump and valve delivery assessments, and evaluate glass container durability (USP-1660).
We deliver testing tailored to meet the specific requirements of each medical device type to analyse and ensure both its proper containment and administration of the drug product. RSSL supports medical device performance testing through the whole method lifecycle, from method development and validation to quality control and release testing, and investigations into troubleshooting.
The biocompatibility of medical devices falls under ISO-10993 regulations, namely the Biological Evaluation of Medical Devices. The evaluation process assesses risk management for chemical species within devices and their possible adverse effects on the end user. Migration of organic and inorganic species from the material used is fully assessed under Extractables and Leachable studies and chemical characterisation of the materials.
RSSL utilises a range of techniques, including mass spectrometers (LC-MS, GC-MS, and ICP-MS) and spectroscopy instruments to ensure any compounds can be quantitatively analysed, and when required, fully elucidated. In addition to the chemical analysis, in vitro cytotoxicity is also involved and performed to USP 87.
Comprehensive material characterisation, encompassing chemical, physical, and biological testing including ISO-10993 are crucial for the development of safe and effective medical devices.
RSSL have strong technical investigative expertise and capability, which can provide support with examinations and analyses of a wide range of medical device failures, including defects and contaminations (including non-destructive 3D imaging capability). We can also support suspected anti-counterfeit investigations and reverse engineering projects.
· Our spectroscopy techniques (FTIR, UV, Raman), chromatography (HPLC, GC, and IC), and mass spectrometry (LC-MS, GC-MS, and ICP-MS) encompass identification and quantification of all organic and inorganic species, whilst also providing further data to understand the interaction between the material and human body.
· Services include a range of mechanical testing through tensile, compression, and flexural tests measurements. RSSL provides a vast range of services including thermal analysis (DSC), thermogravimetric analysis (TGA), surface testing via a host of microscopic techniques (i.e. scanning electron microscopy, light microscopy and profilometry) and dimensional analysis using our state of the art 3D Imaging systems (incl. Micro-CT).
· Sterility and endotoxin testing on medical device key components, and where necessary identify contaminating micro-organisms using our MALDI-ToF, quantifying the microbial load through bioburden testing, or evaluating the integrity of a seal through microbial ingress testing.
RSSL provides GMP and regulatory development of methods and validation for targeted impurities, even at the lowest detection levels as well as to evaluate multiple compounds simultaneously. When an unknown is present, RSSL draws from a wealth of expertise and analytical techniques to structurally elucidate and identify the unknown material or impurity aiding in overcoming any technical or regulatory challenges in the development and manufacturing of medical devices. Using state of the art equipment and techniques including spectroscopy, chromatography, microscopy, and mechanical testing tools, RSSL delivers robust and reliable testing outcomes. We are also able to carry out subvisible and visible particle screening to pharmacopeial specifications for a wide variety of medical devices. Our flexible service packages cater to a wide range of customer needs, from R&D support and regulatory submissions to post-market surveillance.
We currently offer medical device packaging testing to GMP certified standards, ensuring your products meet the highest regulatory requirements. Our services; dye ingress by vacuum and seal integrity testing are two critical methods for ensuring airtight, sterile packaging. These enhancements will provide you with even greater confidence in the safety and reliability of your medical devices.
RSSL’s ability to provide rapid turnaround times without compromising on quality, coupled with direct access to our team of technical specialists makes us your trusted partner. Unlike other providers, we prioritise close collaboration with clients, particularly on projects that require significant technical input or custom study designs. We provide actionable insights, personalised service, and a commitment to excellence that ensures our clients’ success in bringing safe, effective, and compliant medical devices to the market.
