Standard operating procedure

[Audio] Welcome to the Optain SOP Onboarding Session focused on Risk Management..

[Audio] Let's begin with the purpose of our risk management system. At Optain, we are dedicated to ensuring the highest level of safety and efficacy in all our medical devices. To achieve this, we have established a standard methodology for managing risks, encompassing every stage of our device development and manufacturing process. This methodology is not just a procedural formality; it's a cornerstone of our commitment to safeguarding patient and user safety. Furthermore, our system is designed to align with and exceed the requirements of key international regulations, including (EN) ISO 14971, MDR 2017/745, and other critical standards. This alignment demonstrates our dedication to global compliance and excellence. Moving onto the scope of our system, it is all-encompassing within Optain. Every medical device we develop and produce is subject to rigorous risk assessment and management procedures. This is to ensure that we consistently deliver products that meet the highest safety standards for our end-users and patients. Additionally, our risk management extends beyond just product safety. It also includes our Quality Management System, where we have implemented robust controls to mitigate risks in our processes. It is essential to understand that while our QMS and device risk matrices might differ, they are both integral to our overarching goal of excellence in safety and quality..

[Audio] Before we dive into the specifics, let's get acquainted with some key acronyms and definitions that are foundational to our discussion. Take your time or pause the video to get familiar with the terms..

ACRONYMS AND DEFINITIONS. Standard operating procedure.

ACRONYMS AND DEFINITIONS. Standard operating procedure.

[Audio] Now, we're going to navigate through the comprehensive Risk Management Process utilized at Optain. This process begins with a thorough Risk Analysis, where we establish the intended use of our products, anticipate possible misuses, and identify any inherent safety characteristics and potential hazards. Moving into Risk Evaluation, we then estimate the risks associated with each hazard. This leads us to the crucial phase of Risk Control, where appropriate measures are identified and implemented. We don't stop there; we verify these measures and evaluate any residual risks to ensure they are within acceptable limits. At this juncture, we reach a critical decision point - assessing whether the benefits of a product outweigh its risks. Should this balance not be in favor of product safety, we consider modifying the device or implementing additional controls. The final stages of our process involve a thorough Risk Management Review and the ongoing monitoring of production and post-production information. This vigilance ensures that we are ready to reassess risks and adapt our strategies whenever necessary..

[Audio] Now let's dig into each part and begins with Risk Analysis and Evaluation. Initially, we cast a wide net to identify all potential hazards associated with our medical devices, scrutinizing every subsystem under both normal and fault conditions. This meticulous analysis sets the stage for our comprehensive Evaluation. During Evaluation, we delve into the specifics. Each identified hazard is assessed for its severity and the likelihood of occurrence. We refer to standard tables for consistent and objective measurements, classifying risks as either Acceptable or Not Acceptable. It's a disciplined process that aligns with rigorous international standards, including EN ISO 14971:2019 and the EU MDR 2017/745..

[Audio] At Optain, Risk Control is a diligent process that lays the foundation for device safety and compliance. Once we identify risks, we move swiftly to implement control measures. Our approach is in strict adherence to international standards, including EN ISO 14971 and the EU MDR, among others. We prioritize inherently safe design and construction to mitigate risks. For those that cannot be eliminated, we put into place stringent protection measures and ensure that users are fully informed of any residual risks. But what happens when there are risks that linger despite our best efforts? This is where our Residual Risk and Benefit-Risk Analysis comes into play. We assess whether the benefits of using the device outweigh these remaining risks, a process that may involve consulting medical experts. If the balance tips in favor of risk, we may consider a device redesign. The outcomes of these assessments are not taken lightly. They are meticulously documented in the Product Risk Management Report. Any risks that are deemed not acceptable must be disclosed to our users. Ultimately, the decision to move forward with a product rests on a foundation of transparency and a commitment to safety above all else. This rigorous process reflects our unyielding dedication to delivering medical devices that clinicians and patients can trust..

[Audio] Let's take a moment to consider the breadth and depth of our Risk Management Process at Optain. Once we've traversed the demanding landscape of risk analysis, evaluation, and control, we arrive at the pivotal phase of Review. Here, our dedicated Risk Management Review Team scrutinizes every facet of our plan's execution to ensure no stone is left unturned. They verify that every potential risk has been addressed and that the residual risk levels are within acceptable bounds. But our commitment doesn't end at review. We meticulously document our findings in the Risk Management Report, a crucial document that encapsulates the diligence of our review process. This report is not just a formality; it's a testament to our vigilance, approved by the review team and enshrined in the Risk Management File. This file isn't merely a collection of records; it's a living index, a narrative of our product's safety journey. In the arena of Design Inputs, we are just as rigorous. Our risk management activities are intertwined with the design phase, where we preemptively address hazards, always with an eye on safety, risk, and human factors. And let's not forget Usability and Software - areas governed by the stringent standards of the IEC, which we adhere to religiously.

[Audio] As we transition to the production phase of our products, our risk management efforts intensify to ensure that the devices we manufacture meet the highest standards of safety and quality. Our methodologies are rooted in thoroughness: employing Preliminary Hazards Analysis, Failure Modes and Effects Analysis, and Fault Tree Analysis to leave no stone unturned. At each step of manufacturing, we map out potential failure modes and evaluate their severity. This assessment is not just a formality; it's about foresight and prevention. We don't just identify risks; we actively work to prevent them through well-designed controls and processes. We rigorously test our process controls, gathering data to verify that every stage of production is executed flawlessly. And where necessary, we engage in independent verification to ensure that our prevention measures are not just effective in theory but in practice. Ultimately, our decision to move forward with commercialization hinges on the acceptability of residual risk. If the risk is within acceptable limits, we proceed with confidence. If not, we do not hesitate to take additional measures to reduce that risk. This disciplined approach is the essence of our commitment to quality and safety at Optain..

[Audio] As we move beyond the launch of our products, our vigilance does not diminish; it evolves. Post-production risk management at Optain is about ensuring that the safety and integrity of our products endure throughout their lifecycle. We engage both proactively and reactively, assessing risks before any changes are made and gathering data from real-world use. Our sources of information are twofold: operational issues that we control and field issues that come from our users. Both are critical, providing a complete picture of our product's performance in the field. When new failure modes emerge, we don't just take note—we act. Our risk assessments are living documents, continuously updated to reflect the current state of our products. Annually, our Risk Management Review Team reconvenes to reassess our entire process. It's an exhaustive review that ensures our risk management plan remains robust and responsive. We verify that all our control measures are not just in place but effective. We scrutinize the residual risks and determine if they're still acceptable. And importantly, we adapt to any new hazards that have come to light..

[Audio] As we conclude this onboarding session, I'd like to emphasize that our training program at Optain is key to our commitment to excellence and continuous improvement. Thank you all for taking this important step in your journey with us..