Medical Device Design And Development Plan Example

Saturday, October 1st 2022. | Sample

Medical Device Design And Development Plan Example – What is this guide really about? Back in 1998, I started my career as a product development engineer for medical devices. At the time, the FDA Design Controls regulations were still fairly new—not just to me, but to the industry in general. ISO 13485 and the related design and development requirements for the medical device industry were also very new to the industry in the late 90s. At the time, we were all struggling to understand how and what to do with Design Controls. As my career progressed, I began to understand the purpose and intent behind Design Controls. But it didn’t happen overnight. Prior to inception, I was fortunate to play a role in acquiring 40+ medical devices through regulatory approvals in various roles. Since launching our quality management software platform specifically and exclusively for the medical device industry, we’ve been a part of helping dozens and dozens of companies bring their products to market around the world. But for many, Design Controls is a topic that is as confusing today as it was to me years ago. It’s actually quite common for me to hear negative comments about design controls when I talk to product developers. I assure you that if you have a poor sense of design control, it is probably because of the processes you work within; design control is what we do as prudent product developers. Design checks show that our medical devices are safe, effective and meet the indications for use. With this guide, I plan to share valuable insights to explain what design controls are, how to manage them, and how they can benefit your medical device product development efforts. Some key questions and concepts that will be covered in this guide include: How do design controls on simple devices, such as medical devices, apply to complex devices and software? How can risk management practices be integrated throughout the design and development process? Why is design control tracking so important? How do you manage document-based processes to document design controls? You have an idea for a new medical device. Now then? Congratulations! You have an idea for a new medical device. You probably believe that your opinion will have a significant impact on the quality of our lives. Chances are your product will help solve a current problem and fill an unmet need. What are you doing now? There are agencies all over the world that manage and regulate medical devices. For example, in the United States, medical devices are regulated by the Food and Drug Administration (FDA). The EU has a European Competent Authority. Canada has Health Canada. Australian Therapeutic Goods Administration (TGA). And so on. These regulatory bodies have established rules and regulations that you and others who develop and manufacture medical devices must follow. And these regulatory bodies set rules and regulations for how medical devices are classified and what is required before products can be marketed. Most importantly, since you have an idea that you want to develop further, there are set guidelines that you can follow during the product development process. These rules are known as design controls. This may sound confusing and discouraging. I understand that. I don’t want you to be confused or discouraged. This led me to create this “The Ultimate Guide to Designing Controls for Medical Device Companies”. In this guide, I will share with you the necessary information about Design Controls from a global regulatory perspective. I will provide you with knowledge and information that will arm you with more than just the basics. Some clarification on the quality system Yes, I know — this guide should focus on design checks. And it does. I need to take a few minutes to explain to me what a quality system is and how it relates to your efforts to create a medical device. What is a quality system? A medical technology company must establish a quality system. A quality system is a set of processes and procedures that you define and implement to describe how your company manages medical device regulations, including design controls. The FDA sets forth the regulations in 21 CFR Part 820. These regulations are required if you plan to market in the United States. Outside the US, it requires the establishment of a quality system to meet European medical device regulations (and/or IVD regulations). Many medical technology companies choose to implement a quality system to meet the EU’s needs and get it ISO 13485:2016 certified. Canada – same thing. The expectation is to establish a quality system. Canada is a little different, requiring you to create ISO 13485:2016 certification and the Canadian Medical Device Conformity Assessment System (CMDCAS) (and as of January 1, 2019, MDSAP – a single audit medical device audit program). The good news is… FDA 21 CFR Part 820 and ISO 13485 are very similar. In fact, the “new” ISO 13485:2016 is aligned with FDA 21 CFR Part 820.30 on design controls. This is good news and means you can build a “one size fits all” quality system that includes design controls. Build your quality system as you go (for startups) The quality system expectation for medical device startups is to have all parts and pieces defined and implemented when you go to market. Yes, even if you are pre-market, there are parts of FDA regulations and ISO requirements that apply to you. If you develop a medical device, there are at least 4 parts of the quality system that you must perform: Design controls Risk management Document control and records management Supplier management The term I use is “QMS loading”. I encourage this approach. Before, you don’t have to spend a lot of time implementing a strong quality system. You should focus on product development. As you get closer and closer to market, there are more and more software tools you can use to implement QMS. Just make sure you always have your quality system in mind from the start so you don’t have to learn how to get out of a quality system nightmare. What are design controls? So far, I’ve spent very little time discussing design controls in this final guide. Yes, this is intentional. What I have covered so far regarding the classification and understanding of quality systems for medical devices is very important for you to have some knowledge of when bringing your new medical device idea to life. If this information did not deter you and you are still reading, rest assured. The remainder of this guide is devoted to design controls. Really more than just design controls. I will share with you why design controls are important and how they can help you during the development of your medical device. Design controls – Comparison of FDA and ISO It is important that you design and develop a medical device that is safe. The FDA, the European Commission, Health Canada and all other regulatory bodies around the world will want some assurance that your medical device is safe before you release it to the market. And that’s really what Design Management is all about. Proof that you have developed a secure product that meets users’ needs and requirements. Technically, “Design Controls” is an FDA term and is defined in FDA 21 CFR 820.30 (a 21 CFR article is FDA terminology to describe where a substance appears in federal regulations). The terminology and purpose of ISO 13485 is similar and is covered in section 7.3 Design and development. The table below compares the FDA regulations for design controls with the ISO 13485:2016 regulations for design and development. Both FDA Design Controls regulations and ISO 13485 design and development requirements expect you to maintain documentation and records throughout the product development process. A Design History File (DHF) is a good place to store “evidence” of all your design checks. The importance of traceability A good practice is to construct a traceability matrix to show the relationship and relationship between user requirements, design input, design output, design validation and design evaluation. Building and maintaining a traceability matrix using tools like Excel or Google Docs can be a fairly simple task in the first few months of product development. As your project progresses, you will find that using these general-purpose tools, it will take days, if not weeks, to properly update and maintain a traceability matrix. Do not you believe me? Ask an experienced medical device product development project manager how much time it takes to update tracking throughout the project. It probably took 100 hours a year for each project. It’s time to switch to a software solution built specifically to fit your project

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