Medical Device Validation Testing
Patient Guard provides Medical Device Validation Testing Services to ensure clients Medical Devices are safe and effective, helping with regulatory compliance
At Patient Guard Ltd, we understand the critical importance of safety and compliance in the Medical Device industry. Our specialized testing services are designed to provide robust validation data, ensuring that your Medical Devices meet the stringent requirements of applicable testing standards and regulatory requirements.
Biological Endpoint Testing
All Medical Devices that have contact with a patient either directly or indirectly are required to have biological evaluation performed in line with the requirements of ISO 10993. As part of this evaluation process it is sometimes determined that biological endpoint testing is necessary to prove that the Medical Device is biologically safe. This is done through a number of different testing methods based on the number of biological endpoints that have been determined the device needs, this is determined by the type of tissue contact the device has and the duration of contact the device has.
At Patient Guard we are able to provide a range of analytical laboratory techniques following the requirements of the ISO 10993 series of standards for biological evaluation. Along with our Biological Evaluation Plan and Biological Evaluation Report services, we are able to provide a robust biological appraisal of your Medical Devices biological safety.
Biological Evaluation Testing Services
To identify if the materials used in the construction and manufacture of Medical Devices are harmful, it is important that Extractables and Leachables (E&L) testing is performed to determine if any of these chemicals are present and if they are released from the Medical Device over time. Performing E&L testing on the Medical Device provides assurance of the level of biological risk it will present under its intended use.
E&L testing is performed based on the testing requirements set out in ISO 10993-17 (establishment of allowable limits for leachable substances) and ISO 10993-18 (chemical characterization of medical device materials within a risk management process).
Patient Guard Ltd offers a full suite of in vitro cytotoxicity testing services tailored to your specific Medical Device, ensuring compliance with ISO 10993-5 (Tests for in vitro cytotoxicity), this service is delivered though our specially selected GLP certified laboratory partners. Our services include:
- Extract Testing: We prepare extracts from your device materials and assess their potential cytotoxic effects on cultured cells.
- Direct Contact Testing: We evaluate the cytotoxic response by placing your device directly in contact with the cell culture.
- Agar Diffusion Testing: This method involves placing your device on an agar layer to observe any cytotoxic effects on the underlying cells.
ISO 10993-23 (Tests for irritation) relates to skin irritation testing, this standard replaces ISO 10993-10 and now allows for in vitro testing as well as in vivo testing methods for skin irritation tests. At Patient Guard we are against animal testing and therefore we offer the in vitro testing method for indicating if the materials in a medical device are likely to cause skin irritation.
Our lab partner who offers this testing method is GLP certified. Providing an in vitro testing method reduces the costs involved for skin irritation testing significantly compared to using the in vivo method.
Medical Devices that are used to store or channel drugs, such as IV bags and infusion pump administration sets, should be tested to ensure that the drugs that are being administered remain stable during storage duration, or over the administration duration they have with the Medical Device.
As part of a medical devices biological evaluation, Medical Devices that store or channel drugs, should be risk assessed to ensure that the drug maintains its potency, that they do not degrade, and that they do not cause leaching of Medical Device materials, such as plastics into the patient.
Patient Guard though its laboratory partners can provide Drug Stability studies on your drug storage or drug channelling Medical Devices. This testing is integral to demonstrate evidence for Medical Device safety, and regulatory compliance.
It is important to test all drug types that are used in combination with the medical device.
Our Process
- Consultation: We begin with a thorough consultation to understand your device, its materials, and your specific regulatory needs.
- Sample Preparation: Our laboratory partner prepares the necessary extracts and samples from your device materials.
- Testing and Analysis: Using state-of-the-art equipment and methodologies, our lab partner conduct rigorous tests, analyzing the results to ensure accuracy and reliability.
- Reporting: qualified experts provide detailed, comprehensive reports that include all necessary data and findings to support your biological evaluation regulatory submissions.
Our Laboratory Partners
- Certified: All laboratories are certified to ISO/IEC 17025.
- Location: All laboratories are based in the UK.
- GLP compliance: Laboratories that perform Cytotoxicity and In Vitro Skin Irritation testing are GLP certified.
- Quality Assurance: Our partner laboratories adhere to strict quality control protocols to ensure the integrity and reliability of our testing processes.
- State-of-the-Art Facilities: Our partner laboratories are equipped with the latest technology, ensuring precise and accurate testing results.
Why Choose Patient Guard?
- Expertise: Our team of highly skilled scientists have extensive experience in medical device testing and regulatory compliance.
- Regulatory Support: We provide guidance and support throughout the regulatory submission process, helping you navigate complex requirements with ease.
- Medical Device Compliance: Our testing services complement our ability to provide you with a full Medical Device compliance journey.
- One Vendor: Using Patient Guard allows you to use one vendor for your entire regulatory journey
- Time/Money: Using Patient Guard for all your regulatory services will save a significant amount of time and money.
Get Started with Patient Guard Today
Ensure the safety and compliance of your Medical Devices with Patient Guard’s testing services. Contact us today to learn more about how we can help you achieve compliance and bring your innovative medical devices and IVDs to market with confidence.
Find out more about medical device compliance and regulations
The Biological Evaluation of Medical Devices
In healthcare, ensuring the safety and efficacy of medical devices is paramount. Patients rely on these devices for diagnosis, treatment,
In Vitro Skin Irritation Testing: ISO 10993-23 Standard
Skin irritation occurs when a substance causes inflammation or damage to the skin upon contact. For medical devices, this can
Cytotoxicity Testing in Medical Device Biological Evaluation
In the highly regulated world of medical devices, ensuring patient safety is paramount. One of the essential components of this
Drug Stability in Medical Devices: Syringes, Infusion Sets and Bags
Ensuring the stability of drugs in contact with medical devices such as syringes, infusion administration sets and infusion administration bags
Extractables and Leachables Testing for Medical Devices in ISO 10993
In medical device design and development and manufacturing, ensuring the safety and biocompatibility of products is paramount. As part of
