Test Labs Newsletter July 2024

Test Labs Achieves GLP Certification

At Test Labs, our commitment to quality has always been foundational. Our entire laboratory is built on robust quality management systems. We have always approached certifications and accreditations pragmatically, dedicating time and resources to systems that genuinely add value for our customers. Achieving GLP certification is no exception. We identified GLP as a prerequisite and essential requirement to support the medical device industry, especially for clients seeking FDA approvals.

Expert Spotlight

Introducing Toni Carlton:?Our Head of Quality and Compliance.

What do you do at Test Labs??

As Head of Quality and Compliance at Test Labs, my primary responsibility is to ensure that all the processes and procedures are administrated and maintained to the highest standards. My role has several key functions, including quality assurance, regulatory compliance, risk management, training and performance monitoring. Compliance is crucial at Test Labs to ensure testing meets our customer needs, so most recently my role has been focusing on implementing procedures to meet the requirements of GLP and coordinating with the MHRA to gain certification.

Where did your interest in science stem from?

My interest in science has been present for as long as I can remember. As a child, I remember having one of those microscope kits and being excited to look at slides of onion cells and insect wings. Throughout school, Science and Math were always my strongest subjects, which made them really easy for me to enjoy. As I grew older, my fascination with Science deepened, leading me to seek a career in Science where I could help people, without needing to be in a directly people-facing role.

Have you always wanted to work in Compliance?

No, I didn’t originally plan on this career path. I wanted to be a forensic scientist, but when I realized how difficult it was to enter that field, I took a job in the pathology department at a hospital, which led me to become a biomedical scientist. Working closely with my quality manager on method validation, audits, and quality control sparked my interest in compliance, and now I’m grateful to leverage these skills at Test Labs.

What would your advice be for someone thinking of getting into Compliance?

Entering the compliance field demands a blend of education, experience, and commitment. A strong educational background, not just in compliance but also in your specific field, is crucial. Compliance is dynamic, with constantly evolving regulations, so adaptability and a willingness to continuously learn are essential for long-term success.

What is your top tip to medical device manufacturers to keep them compliant?

Start with a solid risk-benefit analysis, as it forms the foundation for a product's entire lifecycle. Map out all device and regulatory requirements, evaluate risks and hazards, and identify existing risk controls to uncover and address any gaps. Embedding this analysis into development and lifecycle management enhances compliance, patient safety, and product quality for medical device manufacturers.

What do you love most about your job?

I love that my job fulfils my career goal of finding a job where I feel like I am helping people without being people-facing. Knowing that my role and the work the team do has a positive impact on the industry and ultimately leads to the safety and reliability of medical devices being used on patients is immensely rewarding.

What do you get up to when you’re not auditing and maintaining the systems at Test Labs?

Between having an extension done on the house and planning our wedding, there hasn’t been much time for anything else lately. I enjoy DIY projects and getting hands-on, so it’s been great to get stuck in. However, when I need a break, I’m likely binge-watching the latest release or the same films over and over again.

My weekends usually consist of watching or attending some form of sport whether that is football, cricket, boxing or Formula 1. I love having something to look forward to, so I am constantly searching for the next event to attend, or the next destination to book.

Medical Device Reprocessing Validation

Before beginning the validation of Instructions for Use (IFUs) for Reusable Medical Devices, it’s crucial to confirm the correct product classification. A medical device is a healthcare product or equipment used for medical purposes. There are over 10,000 different types of medical devices, categorised into four classes based on potential risk to patients and users: Class I, Class IIa, Class IIb, and Class III.

The IFU is a critical component of medical devices, ensuring that devices can be properly cleaned and sterilized without affecting their physical properties. The new regulations mandate that users be informed about the inherent risks, despite measures for safe design and protection. Given the significant public health risks posed by these instruments, the IFU must be validated to confirm that devices can be thoroughly cleaned prior to sterilization. This validation ensures compatibility with both the washer and sterilization cycles, proving that the cleaning process removes all debris and that the device is clean, safe, and sterile for patient us

Follow these 3 simple steps on how to create and validate your IFU:

1. Understand your product – Identifying the medical devices classification and implementing a risk management system is the first step of identifying and reducing the risk to patient safety. This will indicate the requirement of an IFU and its’ validation process.
2. Create a manual – Steps should be taken from the manufacturers IFU or written up based on the products intended clinical use. This should include processes such as automated cleaning, drying and sterilisation.
3. Validate each step – The device should be purposely contaminated, and each step should be validated to ensure that the steps in the manual work to provide a clean device after processing.?

Here's more information for FDA Validation Requirements for Reusable Medical Devices: 21 CFR 801.5

Medical Device Cleaning Validation

At Test Labs, we offer testing services to ensure the cleaning and disinfection instructions outlined in your Instructions for Use (IFU) have been fully validate. As outlined in the ISO 17664 Processing of health care products: Information to be provided by the medical device manufacturer for the processing of medical devices.

Typical Lead Time: under 5 weeks

The Unseen Cost: Why Medical Device Companies Can’t Ignore Regulatory Budgeting

Tautvydas Karitonas

Despite the complexities of medical device development, one issue consistently stands out: the apparent lack of budgeting for regulatory costs, and that is what I want to discuss here. This is an opinion piece, aimed at questioning why regulatory costs are often left out of the budgeting process and what the implications of this oversight might be.