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— Oscar Wilde.
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5 Elements of Medical Device Risk Management
We might have heard that risk assessment and management in the manufacturing of medical devices should be on the top of the priority list. But, do you know what exactly is risk management and what it involves? No, most of us don’t. For a business having a stake in the population’s well-being, it cannot be ignored.
So, here’s an article about the elements involved in assessing the risks of medical devices.
What Exactly is Risk Management?
Risk management is a term defined as a framework implemented to evaluate, detect, and mitigate potential failures throughout the manufacturing process of a medical device. The effectiveness of a medical device can be ensured with risk management during its developing stage. Any medical equipment has to be reliable and safe enough for the operators and the patients. It implies that the medical device should be equally competent for whoever is using it or whoever it is being used on.
Every country has a standard of medical device risk management. For example, the EU medical device regulation sets the standards, and all the organizations have to follow those to evaluate and monitor risk. To get these rules, we have compiled a list of elements that can help you stick to the strictness imposed.
Elements of risk management
These are the steps to be done to implement an acceptable framework of risk assessment and management. Any additions and subtractions must be done carefully.
- Establish a Plan
A Framework that sticks to the compliance standards and is also practical, achievable and can be implemented with reasonable effort should be set and followed. The first step is to define the process of giving an outline to all your employees. Have paperwork that provides evidence for the whole process. Assign duties to the concerned personnel.
Give them something to work for in a safe and convenient environment. Teach them about advanced risk management and also to comply with the documentation with all your responsibilities fulfilled.
- Exactly Define the Assessment Process
After assigning the roles and duties, and conveying procedure of all the documentation, it’s time to define the risk assessment process. The risk management process involves 2 steps, as mentioned below.
- Risk evaluation
- Risk analysis
Both of these Steps have their own role in defining the intensity and amount of risk. For example, evaluation involves the frequency of occurrence and the amount of loss of particular mishappening. Risk analysis means to identify the causes and the situation in which it happened. Both are interrelated.
- Risk Mitigation and Control
Risk mitigation and control have an objective to reduce the risk until it reaches an acceptable level. Now, these objectives can be fulfilled in multiple ways. For example, redesigning the product, making changes to the features, add labels that warn the user about the device, add protective measures in our daily activities, etc. All these tasks can mitigate a considerable amount of risk.
- The Report of Risk Management
As per the documentation, there should always be a risk management report internally made by the organization. Also, the report should stick to accuracy and present facts and figures very clearly. Any deviation can lead to enormous consequences. This report must be signed and acknowledged by every person responsible for risk management.
- Implementing Control Measures from the Feedback
Risk management and control comes when one development cycle ends and the other starts. The period in between is of the feedback given by people involved.
The neutral stakeholders giving feedback about the medical device can be extremely valuable. Some customer complaints should be evaluated to reach a conclusion about the performance of the product in the long and short term. These conclusions must be implemented carefully to find further potential risks.
The industry of medical devices is sensitive, and safety cannot be compromised at all. Due to these reasons, the compliance, and the responsibility of every organization operating in the field are rigorous.
EU Medical Device Regulation: Be Confident of Medical Device Market Approval
Manufacturers of medical devices will soon face major changes in EU regulation decades ago to manage EU market access. MDR replaces the current EU Medical Device Directive (93/42 / EEC) and the EU Transplant-able Medical Device Directive (90/385 / EEC).The Medical Device Regulations were formally released on May 5, 2017, and it came into effect on May 25, 2017. Currently approved medical device manufacturers have a three-year transition period through May 26, 2020, to meet regulatory requirements. For some manufacturers, the new medical device regulation mdr can save additional time after the application date and develop the maximum number of new products four more years in the market. Additional requirements apply during this extended transition period.
How can TÜV help me?
The new MDR places strict requirements on medical device manufacturers and reporting agencies that need to be involved in the approval process for medical devices. The T Product V SÜD Product service is one of the world’s first certification bodies designated as a public body for new medical device regulations, by the National Health Protection Authority (ZLG) for medical products and devices.
With more than 750 medical device professionals in over thirty locations around the world, we are the largest medical device regulatory consultancy licensed to provide certification services under new regulations.
Big changes
MDR differs from the EU directive on implanted and active medical devices in several important ways. The most important changes to the list are:
Product Expansion – The definition of implanted medical devices and implanted medical devices subject to MDR will be expanded to include devices that do not have medical purposes, such as colored contact lenses, cosmetics, and cosmetics. They are also included in a variety of regulated equipment designed to “predict and predict” other diseases and health conditions.
Determination of “Qualified Person” – The device manufacturer must identify at least one person in the organization who is ultimately responsible for all aspects of meeting the new regulatory requirements. The organization must document this person’s specific qualifications for the required tasks. Special relief may apply to so-called SMEs.
Implementation of unique hardware identification: MDRs must use a unique device recognition mechanism (UDI). This requirement is expected to improve the ability of manufacturers and authorities to monitor specific devices throughout the supply chain and to facilitate the rapid and effective recall of safety-critical medical devices. In addition, the European Medical Device Database (Eudamed) is expected to provide effective access to approved medical device information.
Strict Post-Market Control – Aftermarket surveillance by the reporting agencies, MDR seeks increased authority. Undeclared reviews, along with product sampling and product testing, can help strengthen the EU enforcement system and reduce the risk of unsafe devices. In many cases, device manufacturers also need to report annual safety and performance.
- Spec-MDR is a program that allows the EU or the Technical Commission to publish generic specifications that must then be taken into account by manufacturers and reporting agencies. These general specifications must be in combination with uniform standards and the latest technology.
- Re-classify instruments according to the biological evaluation report, risk update, contact time, and MDR device manufacturers, taking into account that Class III and implanted devices have higher clinical requirements and standard audits. Please refer to the classified classification rules and request to update the technical documentation accordingly.
- Stronger clinical evidence for Category III and implanted medical devices – Manufacturers should conduct clinical examinations if there is insufficient clinical evidence to support the safety and function of a dedicated device. Device manufacturers are also required to collect and maintain post-market clinical data as part of the ongoing assessment of potential safety risks.
Systematic Clinical Assessment of Class IIa and Class IIb Medical Devices – Manufacturers will need to re-prepare the clinical evaluation by considering the new language in the timing of equality approaches, the absence of clinical examination can be justified.
Introduce Yourself (Example Post)
This is an example post, originally published as part of Blogging University. Enroll in one of our ten programs, and start your blog right.
You’re going to publish a post today. Don’t worry about how your blog looks. Don’t worry if you haven’t given it a name yet, or you’re feeling overwhelmed. Just click the “New Post” button, and tell us why you’re here.
Why do this?
- Because it gives new readers context. What are you about? Why should they read your blog?
- Because it will help you focus you own ideas about your blog and what you’d like to do with it.
The post can be short or long, a personal intro to your life or a bloggy mission statement, a manifesto for the future or a simple outline of your the types of things you hope to publish.
To help you get started, here are a few questions:
- Why are you blogging publicly, rather than keeping a personal journal?
- What topics do you think you’ll write about?
- Who would you love to connect with via your blog?
- If you blog successfully throughout the next year, what would you hope to have accomplished?
You’re not locked into any of this; one of the wonderful things about blogs is how they constantly evolve as we learn, grow, and interact with one another — but it’s good to know where and why you started, and articulating your goals may just give you a few other post ideas.
Can’t think how to get started? Just write the first thing that pops into your head. Anne Lamott, author of a book on writing we love, says that you need to give yourself permission to write a “crappy first draft”. Anne makes a great point — just start writing, and worry about editing it later.
When you’re ready to publish, give your post three to five tags that describe your blog’s focus — writing, photography, fiction, parenting, food, cars, movies, sports, whatever. These tags will help others who care about your topics find you in the Reader. Make sure one of the tags is “zerotohero,” so other new bloggers can find you, too.
medical device regulation 